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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study summary was made available by ECHA under Article 25, Para 3, of EC Regulation 1907/2006.
Qualifier:
according to guideline
Guideline:
other: OECD 406 and EC Diretive 92/69/CEE
Principles of method if other than guideline:
Magnusson and Kligman Maximisation test.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Intradermal induction: 5% (P/P)
Topical induction: 10% (P/P)
Challenge: 10% (P/P)
Route:
epicutaneous, semiocclusive
Vehicle:
paraffin oil
Concentration / amount:
Intradermal induction: 5% (P/P)
Topical induction: 10% (P/P)
Challenge: 10% (P/P)
No. of animals per dose:
20 test animals (10 males and 10 females)
Challenge controls:
10 negative control animals (five males and 5 females)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% (P/P)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% (P/P). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (P/P)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% (P/P). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% (P/P)
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% (P/P). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% (P/P)
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% (P/P). No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance does not cause skin sensitisation in Guinea-pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Three reliable, GLP compliant, skin sensitisation studies in Guinea–pigs are available. One was undertaken according to the Magnusson and Kligman method (Centre International de Toxicology (C.I.T), 1997) and the other two according to the Buehler method. There was no positive skin response to challenge with the test material in any animal in any of the three studies.


Justification for selection of skin sensitisation endpoint:
The Magnusson and Kligman test is considered more sensitive than the Buehler test.

Justification for classification or non-classification

The test substance is not classified for skin sensitisation, according to EU CLP criteria (Regulation No. 1271/2008).