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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study without detailed documentation.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data: List VI
Author:
Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C., Striegel, J.A.
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Assoc. J., 1962, 23, 95-107

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Similar to the one-day cuff method described by Draize (Draize, J.H., Woodard, G., Calvary, H.O., J. Pharmacol. Exp. Therap., 1944, 82, 377).
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: volatile
Details on test material:
No details on the test material are available.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Type: albino
- Weight at study initiation: 2.5-3.5kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
Duration of exposure:
24 hours
Doses:
Logarithmic series, differing by a factor of 2
No. of animals per sex per dose:
4 animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
LD50 and fiducial range estimated by the method described by Thomson (Thomson, W.R., Bacteriol. Rev., 1947, 11, 115) and Weil (Weil, C.S., Biometrics, 1952, 8, 249).

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw

Applicant's summary and conclusion

Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.