Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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)
Qualifier:
equivalent or similar to guideline
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 chemical
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.