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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
circa 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
Dermal sensitization potential of nitromethane was examined in an intracutaneous test.
GLP compliance:
no
Type of study:
intracutaneous test
Justification for non-LLNA method:
The dermal sensitization potential of nitromethane was examined in an intracutaneous test in guinea pigs, which was already available before the LLNA test was introduced.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
A certificate of analysis supplied with the report indicated that the purity of the test material was 95.88%. The test material also contained 3.31% nitroethane, 0.55% 2-nitropropane and 0.023% water. Other minor impurities were not listed.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No additional information available.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1% with nitromethane

0.03 and 0.3% with DNCB.
Challengeopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1% with nitromethane

0.03 and 0.3% with DNCB.
No. of animals per dose:
10 in test material group, 10 in positive control group and 10 in negative control group
Details on study design:
Groups of 10 guinea pigs received test material , positive control or negative control during the induction phase. The first injection of test material was 0.05 ml. All subsequent injections of test material were 0.1 ml. Since the test material was applied intradermal it is unclear whether the application site was covered or not. Current OECD guidelines indicate that the application site does not need to be covered.
Challenge controls:
Guinea pigs in the negative control group were injected with saline.
Positive control substance(s):
yes
Remarks:
DNCB

Results and discussion

Positive control results:
At 0.3% concentration DNCB, necrosis was observed at the application site. At the 0.03% concentration, a positive response was observed in 8 of 10 guinea pigs.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
Results were considered negative
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Results were considered negative .
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.03%
No. with + reactions:
8
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.03%
No. with + reactions:
8
Total no. in group:
10

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Nitromethane was negative in the intradermal skin sensitization study.
Executive summary:

Nitromethane was evaluated in the intradermal skin sensitization assay and was negative.