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Toxicological information

Acute Toxicity: dermal

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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:
1962
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:
2006
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

Constituent 1
Chemical structure
Reference substance name:
o-toluidine
EC Number:
202-429-0
EC Name:
o-toluidine
Cas Number:
95-53-4
Molecular formula:
C7H9N
IUPAC Name:
o-toluidine
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

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:
No data on clinical symptoms
Body weight:
No data on body weights of the animals at test termination
Gross pathology:
No data on necropsy

Any other information on results incl. tables

Dermal application of 2010 - 5250 ml/kg bw over a period of 24 hours followed by a 14-day observation period yielded a LD50 value of 3250 mg/kg bw using groups of 4 male rabbits and the one-day cuff method of Draize. Signs of toxicity and individual animal data were not reported.

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