Testing Information

Testing Status of Agents at NTP

CAS Registry Number: 110-97-4 Toxicity Effects

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Selected toxicity information from HSDB, one of the National Library of Medicine's databases. 1

Names (NTP)

  • Diisopropanolamine
  • 2-PROPANOL, 1,1'-IMINOBIS- (9CI)

Human Toxicity Excerpts

  • HUMAN EXPOSURE STUDIES: Six out of 24 volunteers exhibited irritant responses when patched tested with neat /diisopropanolamine/, but no irritation occurred in a group of 61 volunteers tested with a 1% aqueous solution. [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • HUMAN EXPOSURE STUDIES: In a repeated patch-test, 25 male and female volunteers had 0.2 mL of a 2% aqueous solution of diisopropanolamine applied to the skin on their backs for 24 hr/day on 3 consecutive days/wk for 3 weeks. After treatment, the application sites were irradiated 3 times with a combination of UVA and UVB rays, at a dose which caused minimal erythema. Thereafter, they were treated only with UVA rays for 6 weeks (at a dose that did not cause erythema), and diisopropanolamine was then applied as patches to 2 sites on the back. One patch remained in place for 24 hours and the site was irradiated at patch removal; the other patch was kept on for 48 hours, and the site was examined for signs of contact dermatitis after removal. Diisopropanolamine did not cause allergic or photoallergic dermatitis. [Institution for Statutory Accident Insurance and Prevention in the Chemical Industry (Berufsgenossenschaft der chemischen industrie); Toxicological Evalution No. 178 Diisopropanolamine p.175 (1991) ]**PEER REVIEWED**
  • HUMAN EXPOSURE STUDIES: ...In 203 volunteers, 0.2 mL of a facial sun-protection cream containing 1% diisopropanolamine was applied to the skin on their backs under occlusive cover for 24 hours. The application site was then examined for irritation. 24 hours later, a further patch was applied for 24 hours and this procedure was repeated for 10 working days. After a 13 day treatment-free interval, a patch was applied for 48 hours to test for sensitization. A second challenge patch was applied 8 days later for 48 hours. During the induction period, 12 volunteers showed irritation of varying degrees of severity. The sun-protection cream induced sensitization in one volunteer. /1% Diisopropanolamine/ [Institution for Statutory Accident Insurance and Prevention in the Chemical Industry (Berufsgenossenschaft der chemischen industrie); Toxicological Evalution No. 178 Diisopropanolamine p.175 (1991) ]**PEER REVIEWED**
  • SIGNS AND SYMPTOMS: Contact dermatitis due to 1,1'-iminodi-2-propanol was observed in occupationally exposed workers. Weak sensitization was observed. [Sheftel, V.O.; Indirect Food Additives and Polymers. Migration and Toxicology. Lewis Publishers, Boca Raton, FL. 2000., p. 939]**PEER REVIEWED**
  • SIGNS AND SYMPTOMS: Inhalation /causes/ sore throat, cough, burning sensation, shortness of breath, labored breathing; symptoms may be delayed. /Contact with skin causes/ pain, redness, blisters, skin burns. /Contact with eyes causes/ pain, redness, /and/ severe deep burns. Ingestion /causes/ burning sensation, abdominal cramps, /and/ shock or collapse. [IPCS, CEC; International Chemical Safety Card on DIISOPROPANOLAMINE (April 1997). Available from http://www.inchem.org/documents/icsc/icsc/eics0493.htm as of September 22, 2005. ]**PEER REVIEWED**
  • CASE REPORTS: A 60-year-old man with gout used indomethacin ointment containing 1% diisopropanolamine /which produced/ a diffuse and edematous, erythema, accompanied by a febrile sensation and severe itching was present. A patch-test with 1% diisopropanolamine in vaseline gave a positive reaction. [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**

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Non-Human Toxicity Excerpts

  • LABORATORY ANIMALS: Acute Exposure: Instillation of 50 mg of DIPA into rabbit eyes caused a burn of eyelid, eyeball, and corneal mucosa. Spontaneous recovery within 22 days. A cataract surrounded by opaque cornea remained after the burn. [Toropkov VV; Gig Tr Prof Zabol 2: 48 (1980) ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: A facial sunscreen containing 1% diisopropanolamine was administered to rats by gavage. A single 5 g/kg dose of undiluted product was given to five male and five female Sprague-Dawley rats following a 16-22 hr fast. No animals died during the 14 day observation period, but one animal had diarrhea 2 hr after administration of the test substance. Nothing abnormal was observed at necropsy. /1% Diisopropanolamine/ [Christian M, ed; J American College of Toxicology 6 (1): 53-73 (1987) ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: A 30% aqueous solution of diisopropanolamine (DIPA) was administered orally to 2 groups of 2 rats. One group received a dose of 2.0 g/kg; DIPA had no observable effects on these rats. The other group received a dose of 3.98 g/kg; both rats died within 24 hr. [Christian M, ed; J American College of Toxicology 6 (1): 53-73 (1987) ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: Poisoning induced severe CNS inhibition, coordination disorder, hypothermia, and diarrhea. Mice appeared to be more sensitive than rats and rabbits. [Sheftel, V.O.; Indirect Food Additives and Polymers. Migration and Toxicology. Lewis Publishers, Boca Raton, FL. 2000., p. 939]**PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: Application of diisopropanolamine /to the eyes of rabbits produced/ distinct erythema with blood extravasation and slight corneal opacity after 24 hr and fading conjunctival hemorrhages after 8 days. [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: Undiluted diisopropanolamine (DIPA) was applied to 7 intact sites and one abraded site on the abdomens of rabbits. Moderate hyperemia and severe necrosis were observed at the intact sites, and slight hyperemia, edema, and moderate denaturation were observed at the abraded sites. A 10% aqueous solution of DIPA was applied to 10 intact sites on the ears of rabbits and 10 intact sites and 2 abraded sites on the abdomens of rabbits. DIPA had no observable effect on the ears of rabbits. Moderate hyperemia and slight blistering were observed at the intact sites, and moderate hyperemia, slight edema, and moderate denaturation were observed at the abraded sites on the abdomens of the rabbits. [Christian M, ed; J American College of Toxicology 6 (1): 53-73 (1987) ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Subchronic or Prechronic Exposure: Fisher 344 rats /were/ exposed /to diisopropanolamine/ continuously in the drinking water at concentrations of 0, 100, 300, 600, 1200, 3000 mg/kg/day for two weeks. Two of five male rats receiving /3000 mg/kg/day/ died, decreases in feed and water consumption, reduction in body size, various alteration in clinical biochemical parameters, reduction in body fat, and organ sizes and weight /were noted/. Acute inflammation and degeneration of kidney and urinary bladder, hepatic atrophy with no other evidence of significant hepatotoxicity /were also reported/. /At 1200 mg/kg/day slight reduction in feed and water consumption, small decreases in body weight in males, slight increase in relative kidney weights with unspecified histologic kidney alterations... /were noted/. At 600 mg/kg/day or less no significant effects /were reported/. /A/ no observable adverse effect level of 600 mg/kg/day /was reported/. [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Subchronic or Prechronic Exposure: Fisher 344 rats /were dermally exposed/ 6 hours /day, 5 days/week at concentrations of 0, 100, 500, or 750 mg/kg/day /for 4 weeks/. No changes in body weight, feed consumption, feed efficiency, hematologic parameters, serum clinical chemistry/electrolyte profiles, urinalysis parameters, terminal body weights, or organ weights indicative of systemic toxicity were observed. No gross or microscopic hepatic, renal or urinary bladder alterations /were observed/ at any dose level tested. Some of the 500 and 750 mg/kg group had slight skin alterations consistent with the irritancy of the material. [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • GENOTOXICITY: Diisopropanolamine was found to be negative when tested for mutagenicity using the Salmonella/ microsome preincubation assay, chemicals, using the standard protocol approved by the National Toxicology Program (NTP). Diisopropanolamine was tested in as many as 5 Salmonella typhimurium strains (TA 1535, TA 1537, TA 97, TA 98, and TA 100) in the presence and absence of rat and hamster liver S-9, at doses of 0.100, 0.333, 1.000, 3.333, and 10.000 mg/plate. The highest ineffective dose tested in any S. typhimurium strain was 10.000 mg/plate. This dose exhibited slight to total clearing of the background bacterial lawn in all strains tested both with and without metabolic activation. [Mortelmans K et al; Environ Mutagen 8:1-119 (1986) ]**PEER REVIEWED**
  • GENOTOXICITY: /In an in vitro cytogenetic assay, Fisher 344 rat lymphocytes /were exposed to diisopropanolamine at/ concentrations of 313, 625, or 1250 ug/mL without S9 mix or 1250, 2500, 5000 ug/mL with S9 mix. No induction of structural chromosomal aberrations /were observed/. [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: The primary skin irritation and phototoxicity of a facial sunscreen product containing 1% diisopropanolamine (DIPA) were evaluated using 7 New Zealand rabbits (4 male and 3 female). Two occlusive patches containing 200 mg product were applied to the clipped backs of 6 rabbits. The seventh rabbit served as a positive control and received 0.5 mL undiluted Oxsoralen, a known phototoxin. After 2 hr, one patch per animal was removed, and the site was exposed to approximately 5X10+7 erg/sq cm uv radiation with wavelengths of 320-450 nm. The test sites were 10 cm distant from the uv source. After uv exposure, patches were replaced for 48 hr, then all patches were removed and the sites were scored for irritation 1,2 24, and 48 hr after patch removal. The group mean primary irritation score was 1.33 (individual animal scores- average of the three readings- were 0.33, 0, 3.33, 2.00, 1.67, and 0.67), the phototoxicity score was 1.50 (individual animal scores- average of the three readings- were 0.67, 0, 2.67, 2.00, 2.67, and 1.00) and the positive control score was 5.33 (scoring scale not given). The difference between the dermal irritation score and the dermal phototoxicity score was not significant. The facial sunscreen was a weak phototoxin and skin irritant. /1% Diisopropanolamine/ [Christian M, ed; J American College of Toxicology 6 (1): 53-73 (1987) ]**PEER REVIEWED**
  • LABORATORY ANIMALS: Acute Exposure: Six New Zealand rabbits (3 male and 3 female) were used to evaluate the primary skin irritation and phototoxicity of a facial sunscreen containing 1% diisopropanolamine (DIPA). Two occlusive patches containing 0.2 mL undiluted product were applied to the shaved backs of each rabbit. Two hours later, one patch per animal was removed , and the test site was exposed for 30 min to UV radiation from a bank of four Sylvania F-40BLB UV bulbs (320-450 nm; peak at 360 nm). After the UV exposure, patches were replaced, then all wrappings and patches were removed 48 hr after the initial application of the test material. Excess product was removed with damp gauze at this time. Test sites were graded 1, 24, and 48 hr after patch removal according to the Draize scoring criteria (max PII of 8). The three scores for each animal were averaged, and group PIIs were calculated. Irradiated and nonirradiated sites had scores of 1 or 2 (max 4) at all three scorings Slight edema was observed at 1 and 24 hr after patch removal. The group PII was 1.2 (max 8) and group phototoxicity PII was 1.3. The facial sunscreen was both a mild primary irritant and phototoxic to skin. /1% Diisopropanolamine/ [Christian M, ed; J American College of Toxicology 6 (1): 53-73 (1987) ]**PEER REVIEWED**

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Human Toxicity Values

  • None found

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Non-Human Toxicity Values

  • LD50 Mouse ip 96 mg/kg [Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996., p. 1253]**PEER REVIEWED**
  • LD50 Rat oral 4765 mg/kg [Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996., p. 1253]**PEER REVIEWED**
  • LD50 Mouse oral 2120 mg/kg [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • LD50 Rabbit oral 4700 mg/kg [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • LD50 Guinea pig oral 2800 mg/kg [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • LD50 Rabbit dermal 8000 mg/kg [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**

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Absorption, Distribution and Excretion

  • 19.5 mg/kg (14)C-DIPA in acetone /was applied dermally/ to an area of skin on the shoulder of four female Fisher 344 rats. After evaporation of the solvent /site of application remained covered for 48 hr/. At 48 hr 25% of the substance had penetrated the skin (12% excreted in the urine, 1% excreted in the feces and expired air, 12.5% remaining in the tissue and 73% was recovered from the application site and surroundings. [European Chemicals Bureau; IUCLID Dataset, diisopropanolamine (110-97-4) (2000 CD-ROM edition). Available from the database query page: http://ecb.jrc.it/esis/esis.php?PGM=ein as of September 19, 2005 ]**PEER REVIEWED**
  • When 4 female Fischer-344 rats were injected iv with 19 mg (14)C-labelled diisopropanolamine in aqueous solution, more than 70% of the radioactivity was eliminated from the blood during the first 6 hr. About 90% of the dose was recovered from the urine within 12 hours. [Institution for Statutory Accident Insurance and Prevention in the Chemical Industry (Berufsgenossenschaft der chemischen industrie); Toxicological Evalution No. 178 Diisopropanolamine p.175 (1991) ]**PEER REVIEWED**

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Metabolism/Metabolites

  • None found

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TSCA Test Submissions

  • None found

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Footnotes

1 Source: the National Library of Medicine's Hazardous Substance Database, 10/28/2007.

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Web page last updated on May 14, 2008