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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.
Qualifier:
according to guideline
Guideline:
other: Annex V (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
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 chemical
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 chemical
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 chemical
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 chemical
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.