Registration Dossier

Administrative data

Description of key information

A GPMT and a Buehler test are available. No effects were observed in these studies.

Justification for selection of skin sensitisation endpoint:

Two K2 studies are available with some deviations and limited reporting.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 June 2011 - 22 July 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has some deviations and the information in the report is limited.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The study has many deviations and the information in the report is incomplete.
- The laboratory has no GLP accreditation.
- No details on animal housing and actual environmental conditions.
- It is not mentioned if water/diet is analyzed for contaminants.
- The LLNA is the preferred test method.
- A minimum of 20 animals is used in the treatment group and at least 10 animals in the control group. In this case 15 animals were used in both the control and test group.
- It is not clear if the induction was performed under occlusion: the area was covered with surgical bandage and fixed with non-irritative tape. These do not seem to be occlusive conditions.
GLP compliance:
no
Remarks:
The study was conducted in China for a Chinese registration. The laboratory has no GLP accreditation.
Type of study:
Buehler test
Justification for non-LLNA method:
study conducted in China and OECD 406 was chosen
Species:
guinea pig
Strain:
not specified
Sex:
male
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
100% 0.2g
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
100% 0.2g
No. of animals per dose:
15
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100% 0.1g
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% 0.1g. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100% 0.1g
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% 0.1g. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% 0.1g
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% 0.1g. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% 0.1g
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% 0.1g. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
2,4-dinitrochlorobenzene mixed in vaselinum was 1.25 mg/g, the amount was 0.2 g.
No. with + reactions:
10
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 2,4-dinitrochlorobenzene mixed in vaselinum was 1.25 mg/g, the amount was 0.2 g.. No with. + reactions: 10.0. Total no. in groups: 15.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
2,4-dinitrochlorobenzene mixed in vaselinum was 1.25 mg/g, the amount was 0.2 g.
No. with + reactions:
10
Total no. in group:
15
Clinical observations:
none
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 2,4-dinitrochlorobenzene mixed in vaselinum was 1.25 mg/g, the amount was 0.2 g.. No with. + reactions: 10.0. Total no. in groups: 15.0. Clinical observations: none.
Interpretation of results:
not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No skin reactions were observed in the test group. Based on the results of this study the substance would not be regarded as a sensitizer.
Executive summary:

No skin reactions were observed in the test group. Based on the results of this study the substance would not be regarded as a sensitizer.

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

Based on the available information the substance is not classified.