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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Test material information:
Composition 1
Species:
other: Guinea pig
Strain:
Dunkin-Hartley
Concentration / amount:
Concentration of test material and vehicle used at induction:
a)Intradermal Induction: 0.5% (w/v) in arachis oil B.P.
b)Topical Induction: 25% (w/w) in arachis oil B.P.
Concentration of test material and vehicle used for each challenge:
a) 10% (w/w) in arachis oil B.P.
b) 5% (w/w) in arachis oil B.P.
Concentration / amount:
Concentration of test material and vehicle used at induction:
a)Intradermal Induction: 0.5% (w/v) in arachis oil B.P.
b)Topical Induction: 25% (w/w) in arachis oil B.P.
Concentration of test material and vehicle used for each challenge:
a) 10% (w/w) in arachis oil B.P.
b) 5% (w/w) in arachis oil B.P.
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5 %
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: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
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: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
5
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: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 10 % Signs of irritation during induction: Well-defined erythema was noted at the intradermal induction sites of all test group animals at the 24 and 48-hour observations. Very slight erythema was noted at the intradermal induction sites of all control group animals at the 24-hour observation and in four control group animals at the 48-hour observation. Very slight to well-defined erythema was noted at the induction sites of all test group animals at the 1-hour observation with very slight erythema at the induction sites of nine test group animals at the 24-hour observation. 50 Bleeding from the intradermal induction sites was noted in five test group animals at the 1-hour observation. Residual test material was noted in all test group animals. Bleeding from the intradermal induction sites was noted in one control group animal at the 1-hour observation. No signs of erythema or oedema were noted at the treatment sites of control group animals at the 1 and 24-hour observations. Evidence of sensitisation of each challenge concentration: Number of animals showing evidence of senitisation at each challenge concentration: 0/10. Other observations: Bodyweight gains of animals in the test group, between day 0 and day 24, were comparable to those in the control group.

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance was not sensitizing on Dunkin-Hartley guinea pigs in an EU Annex V test (1998) conducted under GLP.
Executive summary:

The test substance was not sensitizing on Dunkin-Hartley guinea pigs in an EU Annex V test (1998) conducted under GLP. The test results are considered as valid, and the study is selected as key.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
The test substance is not sensitizing, based on an EU B.6 and OECD 406 test under GLP on Albino Hartley guinea pigs.

Justification for selection of skin sensitisation endpoint:
A valid GLP study conducted under EU Annex V Guideline (1998). Another valid supporting study with similar test result.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Justification for selection of respiratory sensitisation endpoint:
The substance we register as importer is included as an additive in a polymer matrix. The pure substance as such is not available; this route of exposure is not likely.

Justification for classification or non-classification

Based on available evidence on valid GLP tests on guinea pigs, the test substance is not a skin sensitizer.