Registration Dossier
Registration Dossier
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EC number: 202-429-0 | CAS number: 95-53-4
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: Basic data given (No data on mortality, no data on clinical signs, no necropsy and no histopathological examinations were performed/reported)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Range-Finding Toxicity Data List VI
- Author:
- Smyth HF JR, Carpenter CP, Weil CS, Pozzani UC, Striegel JA
- Year:
- 1 962
- Bibliographic source:
- Am Ind Hyg Ass J 23: 95-107
- Reference Type:
- publication
- Title:
- o-TOLUIDINE CAS No: 95-53-4 SIDS Initial Assessment Report.
- Author:
- OECD SIDS
- Year:
- 2 006
- Bibliographic source:
- UNEP Publications
Materials and methods
- Principles of method if other than guideline:
- according to Draize et al., J.Pharmacol.Exper.Therap. 82, 377 (1944)
- GLP compliance:
- no
- Remarks:
- GLP was not mandatory at the time of the study
- Test type:
- standard acute method
Test material
- Reference substance name:
- o-toluidine
- EC Number:
- 202-429-0
- EC Name:
- o-toluidine
- Cas Number:
- 95-53-4
- Molecular formula:
- C7H9N
- IUPAC Name:
- 2-methylaniline
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): o-toluidine
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- -Type of wrap: plastic film
- Duration of exposure:
- 24 h
- Doses:
- No data on the doses employed were given in the publication. However, the publication stated that doses above 20 mL/kg could not be retained in contact with the skin of the animals
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- Penetration of rabbit skin was estimated by a technique closely alike to the one-day cuff method of Draize and associates. Before application, the fur was clipped from the entire trunk of the animals and the substance applied under a plastic film for 24h within which time the animals were immobilized (type of wrap: occlusive). The film was removed at the end of the application period and the animals were subsequently caged and observed for another 14d. LD 50 and its fiducial range were estimated by the method of Thompson (Use of Moving averages and interpolation to Estimate Median Effective Dose. Bacteriol. Rev. 1 115 (June 1947)) using the tables of Weils (Tables for Convenient Calculation of Median-Effective Dose (LD50 or: ED 50) and Instructions in Their Use. Biometrics 8: 249 (Sept. 1952))
- Statistics:
- LD 50 and its fiducial range were estimated by the method of Thompson (Use of Moving averages and interpolation to Estimate Median Effective Dose. Bacteriol. Rev. 1 115 (June 1947)) using the tables of Weils (Tables for Convenient Calculation of Median-Effective Dose (LD50 or: ED 50) and Instructions in Their Use. Biometrics 8: 249 (Sept. 1952))
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 250 mg/kg bw
- 95% CL:
- 2 010 - 5 250
- Mortality:
- No data on mortality
- Clinical signs:
- other: No data on clinical symptoms
- Gross pathology:
- No data on necropsy
Any other information on results incl. tables
Applicant's summary and conclusion
- Executive summary:
Penetration of rabbit skin was estimated by a technique closely alike to the one-day cuff method of Draize and associates using groups of 4 male rabbits. Before application, the fur was clipped from the entire trunk of the animals and the substance (2010 -5250 ml/kg bw) applied under a plastic film for 24h within which time the animals were immobilized (type of wrap: occlusive). The film was removed at the end of the application period and the animals were subsequently caged and observed for another 14d. LD50 value of 3250 mg/kg bw was calculated
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