Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Details not available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
not specified
Justification for non-LLNA method:
The data available for registration was preprared prior to the requirement for the LLNA data. The data are, though, adequate for classification and additional animal data are not justified under te principles of reducing repeat animal testing
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Details not available
Route:
intradermal
Vehicle:
no data
Concentration / amount:
Concentration of test material and vehicle used at induction:Intradermal injection: 7.5% w/w in liquid paraffin.Topical application: 50% w/w in liquid paraffin.Concentration of test material and vehicle used for each challenge:50% and 25% w/w in liquid paraffin.
Route:
other: Not specified
Vehicle:
no data
Concentration / amount:
Concentration of test material and vehicle used at induction:Intradermal injection: 7.5% w/w in liquid paraffin.Topical application: 50% w/w in liquid paraffin.Concentration of test material and vehicle used for each challenge:50% and 25% w/w in liquid paraffin.
No. of animals per dose:
Number of animals in test group: 20Number of animals in negative control group: 10
Details on study design:
Details not available
Challenge controls:
Not specified
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 6.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
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: 25%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
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: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.

Signs of irritation during induction: Not specified

Evidence of sensitisation of each challenge concentration: No evidence of delayed contact hypersensitivity seen in any of the test 20 animals.

Localised dermal reactions were observed (restricted to a small area of the challenge site).

Other observations: The dermal reaction seen in the test animals were similar to those seen in the controls.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Not sensitising
Executive summary:

The skin sensitisation was determined using the OECD 406 and EU B6 test methods. Details are not available, but the data has been reviewed by a suitable EU Competent Authority and provided by ECHA. The test substance is not sensitising.     

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Skin Sensitisation: Not sensitising (Guinea Pig) [Key study & supporting study].

Justification for selection of skin sensitisation endpoint:
Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.

Justification for classification or non-classification

The substance is not classified under CLP as it does not fill the requirements for skin sensitising classification.