Registration Dossier
Registration Dossier
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EC number: 205-011-6 | CAS number: 131-11-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is acceptable with restrictions and sufficient for endpoint evaluation. Restrictions are 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:
- 1 948
- Bibliographic source:
- Journal of Pharmacology and Experimental Therapeutics
- Reference Type:
- review article or handbook
- Title:
- Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes
- Author:
- Draize JH et al.
- Year:
- 1 944
- Bibliographic source:
- J. Pharmac. Exp. Ther. 82: 377-390
- Reference Type:
- secondary source
- Title:
- Pattys Industrial, Hygiene and Toxicology
- Author:
- Clayton GD und Clayton FE (eds.)
- Year:
- 1 981
- Bibliographic source:
- Pattys Industrial, Hygiene and Toxicology, 3rd ed., Vol. 2A: 2347
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- ECB-IUCLID
- Year:
- 2 000
- Bibliographic source:
- European Chemicals Bureau, 11-FEB-2000
- Reference Type:
- secondary source
- Title:
- Insect Repellents
- Author:
- Lehman AJ
- Year:
- 1 955
- Bibliographic source:
- Assoc. Food and Drug Officials 19: 87-99
Materials and methods
- Principles of method if other than guideline:
- Method: A method of Draize et al. (1944) was followed. Neat material was held in contact with clipped skin for 24h (occlusive) by a rubber sleeve. Prior to exposure the subjects are prepared by clipping the skin of the trunk free of hair. Approximately half of the animals are further prepared by making epidermal abrasions longitudinally over the area of exposure two centimeters apart. Depilation or shaving causes sufficient disturbance of the stratum corneum so that a 24h period is necessary for the recovery of the skin before exposure to the agent. Clipping the hair with small animal clippers was preferred since the intact skin remains undisturbed. The sleeve is slipped onto the animal which is then placed in a comfortable but immobilized position in a multiple animal holder. The doses of liquids and solutions are calculated on tile basis of body weight and introduced under the sleeve.
- GLP compliance:
- no
- Test type:
- other: historical test according to Draize et al. (1944)
- Limit test:
- yes
Test material
- 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
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dimethyl phthalate; CAS-No.: 131-11-3
- Other: no further data
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Doses:
- - 3.9, 6.0 and 9.4 ml/kg bw in a preliminary range finding
- during the main test, graded dose grops were applied; no further details on single doses given - Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: blood morphology
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 12 000 mg/kg bw
- Remarks on result:
- other: calculated from original data 10 ml/kg (density 1.194 g/ml)
Applicant's summary and conclusion
- Conclusions:
- LD50 in rabbit for acute dermal toxicity of >12000 mg/kg bw was reported (original data: LD50 >=10 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). Test substance was tested in rabbits (undiluted test substance) for acute dermal toxicity.
An LD50 in rabbit for acute dermal toxicity of >12000 mg/kg bw was reported (original data: LD50 >10 ml/kg bw, density 1.194 g/ml).
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