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)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
existing study available from publication
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Route:
other: intradermal and epicutaneous occlusive
Vehicle:
not specified
Concentration / amount:
100%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
100%
No. of animals per dose:
Test group: 15
control group: 6
Positive control substance(s):
yes
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
no data
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
no data
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
15
Total no. in group:
15
Clinical observations:
no data
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No studies were conducted on the target substance. As the target substance hydrolyses rapidly (half-life < 5 minutes) the intrinsic properties are related to hydrolysis products of the target substance, 1 -butanol.

There is also no skin sensitisation studies available for 1 -butanol. The structurally-related primary alcohol 1 -propanol showed no allergenic properties in a mouse ear swelling test, in a guinea pig maximisation test of in occluded patch tests (Gad et al, 1986)

 

Based on these findings, the target substance was considered not skin sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The target substance is not classified as skin sensitizer according to CLP Regulation.