Registration Dossier
Registration Dossier
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EC number: 205-011-6 | CAS number: 131-11-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is reliable with restrictions due to limited reporting (non-GLP study). Basic data are given and study is sufficient for endpoint evaluation.
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 93:26-39
- 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:
- publication
- Title:
- Insect Repellents
- Author:
- Lehman AJ (5).
- Year:
- 1 955
- Bibliographic source:
- Assoc. Food and Drug Officials 19: 87-99
- Reference Type:
- secondary source
- Title:
- Toxicity Profile, Dimethylphthalate, November 1987
- Author:
- BIBRA
- Year:
- 1 987
- Bibliographic source:
- BIBRA
- Reference Type:
- secondary source
- Title:
- No information
- Author:
- ECB-IUCLID
- Year:
- 2 000
- Bibliographic source:
- European Chemicals Bureau, 11-FEB-2000
Materials and methods
- Principles of method if other than guideline:
- Method: historical Method according to Draize et al. (1944). See any further information on materials and methods for details.
- GLP compliance:
- no
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
- Physical state: no data
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Test animals
- Species:
- rabbit
- Strain:
- other: only mentioned: albino rabbit
- Details on test animals or test system and environmental conditions:
- no details reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml neat test substance; density =1.194 g/ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24-72h reading
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: patch size 2.5 x 2.5cm, four patches are placed at the back of the animal, 10cm apart
- Type of wrap if used: rubberized cloth, wrapping the whole animal trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 24h patch exposure
SCORING SYSTEM: "the primary irritation index" according to Draize etal. (1948)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- skin
- Basis:
- mean
- Time point:
- other: 24-72h combined average
- Score:
- 0.7
- Reversibility:
- other: no substance-related effects
- Remarks on result:
- other: combined average is based on averages from intact and abraded rabbit skin
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not cause skin irritation but irritation of mucous membrane.
The test substance is not irritating to the skin. - Executive summary:
The study was conducted according to the method described by Draize et al. (1944) and is reliable with acceptable restrictions. Restrictions are due to limited reporting in times befor GLP. Skin irritation was tested in albino rabbits in vivo. Neat test substance (0.5ml unchanged, no vehicle) was applied on abraded and intact skin (occlusive) for 24h (reading 24 -72h).
The test substance is not irritating to the skin.
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