Registration Dossier

Administrative data

Description of key information

According to the test results the substance is not classified for skinsensitization

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
USE OF (ROBUST) STUDY SUMMARIES PROVIDED BY ECHA, the study data of the Robust Study Summaries are older than 12 years
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no further data available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
USE OF (ROBUST) STUDY SUMMARIES PROVIDED BY ECHA, the study data of the Robust Study Summaries are older than 12 years
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Maximization test
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
USE OF (ROBUST) STUDY SUMMARIES PROVIDED BY ECHA, the study data of the Robust Study Summaries are older than 12 years
Specific details on test material used for the study:
no further data available
Species:
guinea pig
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
no further data available
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
1% (w/w( in PEG 400
Day(s)/duration:
day 1
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
2% (w/w) in 50:50 mix of Freund's adjuvant/dist. water
Day(s)/duration:
day 1
Adequacy of induction:
not specified
Route:
other: epidermal
Vehicle:
polyethylene glycol
Concentration / amount:
10% (w/w) in PEG 400
Day(s)/duration:
day 7
Adequacy of induction:
other: max concentration not giving rise to irritating efects in the preliminary test
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
5% in PEG 400
Day(s)/duration:
day 22 / 24 and 48 hours duration
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
2% in PEG 400
Day(s)/duration:
day 22 / 24 and 48 hours duration
Adequacy of challenge:
not specified
No.:
#3
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
1% in PEG 400
Day(s)/duration:
day 22 / 24 and 48 hours duration
Adequacy of challenge:
not specified
No. of animals per dose:
20 females per test group
10 females in negative control group
Details on study design:
no further data available
Challenge controls:
10 females
Positive control substance(s):
not specified
Positive control results:
no further data available
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
2%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
2%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
2%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as skin sensitizer according to the CLP/GHS criteria
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification