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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:
other: Study used for notification under 67/548. Original study report not available.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route:
intradermal and epicutaneous
Vehicle:
other: Alembicol D
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 1 % w/v
b) Topical: 50 % w/v
Concentration of test material and vehicle used for each challenge:
a) Topical: 50 % w/v
b) Topical: 25 % w/v
Route:
other: epicutaneous, not further specified
Vehicle:
other: Alembicol D
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 1 % w/v
b) Topical: 50 % w/v
Concentration of test material and vehicle used for each challenge:
a) Topical: 50 % w/v
b) Topical: 25 % w/v
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified
Positive control results:
no data
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the study, no symptoms of skin sensitising were observed. The results are conclusive but not sufficient for classification.
Executive summary:

The study was conducted according to Guideline EU B.6.

An Induction dose of 1 % w/v test substance in the vehicle was administered topical and intradermal.

Two challenge doses of 25 and 50 % w/v test substance in the vehicle were applied.

No signs of effects were noted during the study period.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
An in vivo skin sensitisation study is available and no adverse effects are reported.

Justification for selection of skin sensitisation endpoint:
An in vivo skin irritation/corrosion study is available and no adverse effects are reported.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
The presented substance has no indication for skin sensitisation and is therefore not a respiratory sensitiser either (REACH technical guidance document on information requirements and chemical safety assessment: scheme of R.7a, Fig 7.3-2). In addition, the substance has a low volatility (vapour pressure < 0.01 kPa).

Justification for classification or non-classification

The study results are conclusive but not sufficient for classification.