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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
(a) Intradermal induction: 0.5% (w/v) in arachis oil BP
(b) Topical induction: 25% (w/w) in arachis oil BP

Concentration of test material and vehicle used for each challenge:
(a) 10% (w/w) in arachis oil BP
(b) 5% (w/w) in arachis oil BP
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
(a) Intradermal induction: 0.5% (w/v) in arachis oil BP
(b) Topical induction: 25% (w/w) in arachis oil BP

Concentration of test material and vehicle used for each challenge:
(a) 10% (w/w) in arachis oil BP
(b) 5% (w/w) in arachis oil BP
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 tests: 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.

Bleeding from the intradermal industion 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 treatement 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 sensitisation 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 hte control group.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are two available studies to determine if the substance is skin sensitising or not. Both of them were done following GLP.

In a study performed in 1993 according to OECD Guideline 406, no positive reaction was observed.

In a study performed in 1998 according to EU Test Method B6 (Guinea pig maximisation test), no positive reaction was observed.


Migrated from Short description of key information:
There isn't any positive reaction observed in both of the studies done.

Justification for selection of skin sensitisation endpoint:
There are two test results available, with same results.
This endpoint has been selected because the information given is better described.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The values obtained have been compared to criteria set up in the Annex I of the Regulation (section 3.4). As a result the substance is not considered to be classified as skin sensitising under Regulation (EC) No. 1272/2008.