Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Referenceopen allclose all

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 Type:
secondary source
Title:
No information
Author:
ECB-IUCLID
Year:
2000
Bibliographic source:
European Chemicals Bureau
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

Constituent 1
Chemical structure
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).