Registration Dossier

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:
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.

Data source

Reference
Reference Type:
other: Provided by ECHA
Title:
Unnamed
Year:
2004

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:
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Details not available

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Details not available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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.
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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 group
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 group
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.