1.0 Submitter/Company Information

Submitter Comments


2.0 Submission Information

EPA Receipt Date: 08/27/92

8(e)/FYI ID Number: 8ECP-0892-09343A-02

Submission Stage: INI

Document Control Number: 88920007665

3.0 Chemical Information
CAS Number: 131-11-3

TSCA Chemical Inventory Name: 1,2-Benzenedicarboxylic acid, dimethyl ester

Synonyms: MIXTURE:

Other Chemicals in Submission:
CAS Number: 000131113
Chemical Name: DIMETHYL PHTHALATE

4.0 Study Information

Study Information:
Unknown Environmental Effects

Summary/Abstract:
ACUTE ORAL TOXICITY IN MALE AND FEMALE SPRAGUE-DAWLEY ALBINO RATS IS OF LOW
CONCERN. SINGLE DOSES OF 794, 1000, 1260 OR 1580 MG/KG GAVAGED ALTERNATELY TO
GROUPS OF EITHER 2 MALE AND 3 FEMALE RATS OR 3 MALE AND 2 FEMALE RATS WERE
ASSOCIATED WITH SIGNS OF NEUROTOXICITY AND MORTALITY AS FOLLOWS: 794 MG/KG
(0/2M, 0/3F), 1000 MG/KG (1/3M, 0/2F), 1260 MG/KG (0/2M, 2/3F), 1580 MG/KG
(3/3M, 2/2F). A COMBINED ORAL LD50 FOR MALE AND FEMALE RATS WAS 1300
(1065-1585) MG/KG. OVERT CLINICAL OBSERVATIONS INCLUDED WEAKNESS, DYSPNEA,
LACRIMATION, SALIVATION AND CONVULSIONS. PULMONARY HYPEREMIA WAS THE ONLY
PATHOLOGY NOTED ON NECROPSY.

ACUTE DERMAL TOXICITY IN MALE AND FEMALE NEW ZEALAND WHITE RABBITS IS OF LOW
CONCERN. SINGLE OCCLUDED 24-HOUR APPLICATIONS OF 1000, 1580, 2510, 3980, 6310
OR 10,000 MG/KG TO THE INTACT SKIN OF ONE MALE OR FEMALE RABBITS WERE
ASSOCIATED WITH SIGNS OF NEUROTOXICITY AND DEATH OF THE ONE MALE TWO DAYS
FOLLOWING THE DERMAL APPLICATION AT A DOSAGE OF 10,000 MG/KG. OVERT CLINICAL
SIGNS OF SYSTEMIC TOXICITY INCLUDED WEAKNESS, LETHARGY AND TREMORS. NECROPSY
FINDINGS NOTED LIVER DISCOLORATION ONLY.

DERMAL IRRITATION IN MALE AND FEMALE ALBINO RABBITS IS OF LOW CONCERN. SINGLE
OCCLUDED 24-HOUR APPLICATIONS OF UNDILUTED TEST MATERIAL TO THE INTACT SKIN OF
2 MALE AND 1 FEMALE RABBITS WERE ASSOCIATED WITH NO SIGN OF
IRRITATION IN ANY ANIMAL (MEAN DRAIZE SCORE = 0/8) THROUGHOUT 160-HOUR
OBSERVATION.

EYE IRRITATION IN MALE AND FEMALE ALBINO RABBITS IS OF MEDIUM CONCERN. SINGLE
24-HOUR INSTILLATIONS INTO THE RIGHT CONJUNCTIVAL SAC OF 2 FEMALE AND 1 MALE
RABBITS WERE ASSOCIATED WITH 1HOUR IRRITATIVE SIGNS INCLUDING MILD EDEMA,
MODERATE REDNESS COPIOUS DISCHARGE AND MODERATE IRIDIC CONGESTION COMPRISING AN
AVERAGE DRAIZE SCORE FOR 3 ANIMALS OF 37.6. AT 7TH DAY OBSERVATION, ALL
IRRITATIVE EFFECTS WERE COMPLETELY RESOLVED IN 1/3 ANIMALS; TWO ANIMALS
CONTINUED TO SHOW OCULAR EFFECTS AS REPRESENTED BY AN AVERAGE DRAIZE SCORE OF
3.3/110. NO IRREVERSIBLE DAMAGE WAS DEMONSTRATED IN ANY ANIMAL.

ACUTE INHALATION IN MALE RATS IS ASSIGNED A MEDIUM LEVEL OF CONCERN. SINGLE
60-MINUTE EXPOSURES TO 4.5 CC VAPORIZED AND SUPPLIED AT A RATE OF 4 L/MIN TO
FOUR MALE RATS IN A GLASS DESICCATOR OF 250 MM DIAMETER WITHOUT FURTHER
ATMOSPHERIC SUPPLEMENTATION WERE ASSOCIATED WITH DEATH OF ALL ANIMALS WITHIN
ONE HOUR OF INITIATION OF THE EXPOSURE. OVERT CLINICAL OBSERVATIONS INCLUDED
CLOSED EYES UPON EXPOSURE, DYSPNEA, INCREASING WEAKNESS, GASPING, COLLAPSE AND
COMA. POSTMORTEM AUTOPSY IDENTIFIED SWOLLEN AND IRRITATED NASAL AND OCULAR
MUCOSAE, HEMORRHAGIC AREAS IN THE LUNGS AND LIVER HYPEREMIA.