Dimethyl phthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is sufficient for endpoint evaluation with acceptable restrictions due to limited reporting (non-GLP study).

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Toxicological investigations of compounds proposed for use as insect repellants, A. Local and system effects following topical skin application. B. Acute oral toxicity. C. Pathological Examination

Author:

Draize JH

Year:

1948

Bibliographic source:

Journal of Pharmacology and Experimental Therapeutic

Reference 2

Reference Type:

secondary source

Title:

No information

Author:

ECB-IUCLID

Year:

2000

Bibliographic source:

European Chemicals Bureau

Reference 3

Reference Type:

secondary source

Title:

Insect Repellents Assoc.

Author:

Lehman AJ

Year:

1955

Bibliographic source:

Food and Drug Officials 19: 87-99

Materials and methods

Principles of method if other than guideline:

Method: other - "Acute oral toxicity" testing, animals were starved 18h prior to treatment (exept mice), administration of graded doses to groups of ten animals, recording of dosage-mortality curves (LD50 estimation)

GLP compliance:

no

Test type:

other: Acute oral toxicity according to Draize (1948)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl phthalate

EC Number:

205-011-6

EC Name:

Dimethyl phthalate

Cas Number:

131-11-3

Molecular formula:

C10H10O4

IUPAC Name:

1,2-dimethyl benzene-1,2-dicarboxylate

Test material form:

liquid

Specific details on test material used for the study:

IUCLID4 Test substance: other TS

TS-Freetext:
Dimethyl phthalate;
CAS-No.: 131-11-3;
no further data

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 18h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

not reported

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 6 days
- Necropsy of survivors performed: no
- Other examinations performed: other: mortalities were recorded

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

8 200 mg/kg bw

Remarks on result:

other: Original data: LD50 = 6.9 ml/kg bw, density = 1.194 g/ml; Calculation: LD50 = 8200 mg/kg bw

Mortality:

mortality occured within 7h to 3days post application

Clinical signs:

other: - animals exhibited drowsiness and listlessness within 15min after application - high doses produced a state not unlike anesthesia

Applicant's summary and conclusion

Conclusions:

LD50 in rat for oral gavage of 8200 mg/kg bw was determined (original data: LD50 = 6.9 ml/kg bw, density 1.194 g/ml).

Executive summary:

The study is sufficient for endpoint evaluation with acceptable restrictions due to limited reporting (non-GLP study). Dimethyl phtalate was tested in rats (undiluted test substance). Oral toxicity via gavage was tested with neat substance in rats. Mortalities occurred. Signs of intoxication in the rat included drowsiness within the first 15 min after an acute oral dose. Animals rapidly became semi-conscious, deaths occurred between 7 h and 3 days.

An LD50 in rat for oral gavage of 8200 mg/kg bw was determined (original data: LD50 = 6.9 ml/kg bw, density 1.194 g/ml).