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Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
Lot No.: 101155
odourless white solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
100% 0.2g
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
water
Concentration / amount:
100% 0.2g
No. of animals per dose:
15

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.