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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a detailed method. Not GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Ten female guinea pigs were used in the treatment group. The compound was administered in a series of ten "sensitizing" injections into the lower back and flanks of the guinea pigs. Two weeks after administration of the tenth sensitizing injection, a challenge injection of 0.05 mL was administered. The volume of the first injection was 0.05 mL and that of the other nine was 0.10 mL.
GLP compliance:
not specified
Type of study:
other: K. Landsteiner and J. Jacobs, "Studies on the Sensitization of Animals with Simple Chemical Compounds," J. Exp. Med. 61, 643-656 (1935).

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material : 3-NITRO-1 ,2,4-TRIAZOL-5-0NE (NTO)
- Substance type: energetic explosive
- Physical state: light green to white crystalline solid with no odor
- Purity ca.99%
Specific details on test material used for the study:
Batch No.: not specified
Purity: not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 363-438 g
- Housing: The animals were housed individually.
- Diet (e.g. ad libitum): The animals were fed commercial laboratory stock diet ad libitum supplemented by daily lettuce, cabbage, or apples because of their need for dietary fiber.

No additional data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
0.1%
Challengeopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
0.1%
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Test groups: ten female animals
- Site: lower back and flanks
- Duration: 24 hours
- Concentrations: The volume of the first injection was 0.05 mL and that of the other nine was 0.10 mL .

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks after the topical induction.
- Exposure period: 24 hours
- Test groups: ten female animals
- Site: lower back and flanks
- Concentrations: 0.05 mL

No additional data
Challenge controls:
None stated
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Group:
test group
Dose level:
0.1%
Total no. in group:
10
Remarks on result:
other: Review of the data collected for each guinea pig in the treatment group indicates that all challenge injections were within the limits of the reactions recorded during the sensitizing period.
Remarks:
The guinea pig skin sensitization study did not show NTO to be a sensitizer.

Any other information on results incl. tables

Review of the data collected for each guinea pig in the treatment group indicates that all challenge injections were within the limits of the reactions recorded during the sensitizing period. The guinea pig skin sensitization study did not show the test substance to be a sensitizer.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The material did not induce sensitization in the intradermal guinea pig assay.