Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
other: USE OF (ROBUST) STUDY SUMMARIES PROVIDED BY ECHA, the study data of the Robust Study Summaries are older than 12 years
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
no further data available

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
no further data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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

Results and discussion

Positive control results:
no further data available

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as skin sensitizer according to the CLP/GHS criteria