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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Performed under GLP and according to guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Non LLNA stury results where already available at the time of registration.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: avid Hall
Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks old.
- Weight at study initiation: 328 to 395g
- Housing: ingly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -22
- Humidity (%): 48-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Concentration / amount:
Intradermal Induction: 0.5% w/v in distilled water, 0.5% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
(1: 1)
Topical Induction: 25% v/v in distilled water
Topical Challenge: 25% and 10% v/v in distilled water
Route:
epicutaneous, occlusive
Concentration / amount:
Intradermal Induction: 0.5% w/v in distilled water, 0.5% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
(1: 1)
Topical Induction: 25% v/v in distilled water
Topical Challenge: 25% and 10% v/v in distilled water
No. of animals per dose:
5 control, 10 test animals
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
10
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: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
6
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: 6.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% and 25%
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% and 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The substance is sensitising to guinea pig skin
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Migrated from Short description of key information:

Based on a  Guinea Pig Maximisation test the substance is found sensitising.

Justification for selection of skin sensitisation endpoint:

One study is available for the substance, a guinea-pig maximisation study.

Justification for classification or non-classification

The substance should be classified a sensitising to skin.