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:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The study used the footpad method, as mentioned in the OECD 406 guidelines (1981)
GLP compliance:
no
Remarks:
However was subject to Quality Assurance
Type of study:
other: Foodpad method
Justification for non-LLNA method:
Study available from 1989, LLNA method not yet accepted guideline
Species:
guinea pig
Strain:
other: Cr1:(HA)BR Hartley
Sex:
female
Route:
intradermal
Vehicle:
other: Acetone/dioxane/guinea pig fat
Concentration / amount:
Induction: 1% w/v
Challenge: 10% w/v
Route:
epicutaneous, open
Vehicle:
other: Acetone/dioxane/guinea pig fat
Concentration / amount:
Induction: 1% w/v
Challenge: 10% w/v
No. of animals per dose:
10 females
Challenge controls:
10 females
Positive control substance(s):
not specified
Positive control results:
Not applicable
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10% w/v
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% w/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0.

No reaction was observed at challenge in any animal.

Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
HQEE was not a skin sensitiser in this assay
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

HQEE gave a negative response in a reliable Footpad study.
Migrated from Short description of key information: HQEE is not a skin sensitiser

Justification for selection of skin sensitisation endpoint: Only one study available. Study is Klimisch 2.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

HQEE gave a negative response in a Footpad study and is therefore not classified.