Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

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: epidermal & challenge exposure: vaseline
Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal (0.1 mL)
a) adjuvant/saline 1:1
b) test substance 1% in sesame oil
c) test substance 1% in the saline/adjuvant 1:1 mixture

Epidermal (approx. 0.4 g)
test substance 30% in vaseline

- Concentration of test material and vehicle used for each challenge:
Epidermal (approx. 0.2 g)
10% of the test substance in vaseline
Challengeopen allclose all
Route:
other: no data
Vehicle:
other: epidermal & challenge exposure: vaseline
Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal (0.1 mL)
a) adjuvant/saline 1:1
b) test substance 1% in sesame oil
c) test substance 1% in the saline/adjuvant 1:1 mixture

Epidermal (approx. 0.4 g)
test substance 30% in vaseline

- Concentration of test material and vehicle used for each challenge:
Epidermal (approx. 0.2 g)
10% of the test substance in vaseline
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

The field "Clinical observations" cannot be provided because the NONS file (provided by ECHA) doesn't contain this information.

Number of animals showing evidence of sensitisation at challenge concentration (10%): 0/20 of the animals showed sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified as sensitising to the skin.