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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Maximization Test of Magnusson and Kligman
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 1st induction: sesame oil and adjuvant saline mixture; 2nd induction and challenge exposure: vaseline
Concentration / amount:
- Concentration of test material and vehicle used at induction:
First induction (intradermal injection): 1% in sesame oil and adjuvant saline mixture.
Second induction (epidermal application): 30% in vaseline.
- Concentration of test material and vehicle used for each challenge: 3% in vaseline.
Challengeopen allclose all
Route:
other: no data
Vehicle:
other: 1st induction: sesame oil and adjuvant saline mixture; 2nd induction and challenge exposure: vaseline
Concentration / amount:
- Concentration of test material and vehicle used at induction:
First induction (intradermal injection): 1% in sesame oil and adjuvant saline mixture.
Second induction (epidermal application): 30% in vaseline.
- Concentration of test material and vehicle used for each challenge: 3% in vaseline.
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3 %
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3 %. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3 %
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 3 %

Signs of irritation during induction: 10% in vaseline induced erythema reactions.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Because all reactions observed in the standard challange were mild a 2nd challenge application was performed. In this 2nd test only 5% of the animals were judged to have been sensitized by the test compound which leads to the conclusion that the reactions observed in the first application were not specific. As it may happen in adjuvant treated animals the substance is not classified as sensitizer according to the Directive.