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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:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 406: GLP.
Justification for type of information:
The justification for read across is provided as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 406: GLP.
Justification for type of information:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.4 ml of 0.1% w/v suspension in acetone.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.4 ml of 0.1% w/v suspension in acetone.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.

The skin reactions after challenge applications were:

Test group - No dermal irritation in any animal;

Naive control group - Very slight erythema in two animals, no reaction in the other eight animals;

Vehicle control group - A very slight erythema in one animal, no reaction in the other nine animals;

Positive control group - Very slight to severe irritation in all 20 animals. The reaction in 19 animals exceeded the highest reaction observed in the naive positive control animals;

Naive positive control group - 5 of 20 animals exhibited very slight erythema, the other 15 animals had no skin reaction.

Interpretation of results:
other: Not sensitising
Conclusions:
Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

This data is being read across from the source study that tested Kerosene based on analogue read across.

0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Reference Type:
other: HPV Summary
Title:
Robust Summary of Information on Substance Group: Kerosene/Jet Fuel
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
Robust Summary of Information on Substance Group: Kerosene/Jet Fuel. 2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Acceptable Buehler test that followed sound scientific principles.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Straight run kerosene

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
0.4 ml of a 1% solution in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
0.4 ml of a 1% solution in paraffin oil
No. of animals per dose:
10 animals
Details on study design:
0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. The same skin site was used for the first two applications but due to the severe irritation that had occurred in the test and positive control groups a different site was used for the third sensitizing application. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. The application sites for sensitizing and challenge doses were scored for erythema and edema 24 and 48 hours after patch removal. To assist in the scoring of the response to the final challenge dose the test site was depilated 3 hours prior to examination by using a commercially available depilatory cream. Positive control (2,4-dinitrochlorobenzene), vehicle control and naive control groups were included in this study. Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.
Positive control substance(s):
yes
Remarks:
Sensitizing doses:2,4-dinitrochlorobenzene: Concentrations of positive control were as follows: Sensitizing doses: 0.4 ml of 0.3% w/v in 80% aqueous ethanol Challenge dose: 0.4 ml of 0.1% w/v suspension in acetone.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.4 ml of 0.1% w/v suspension in acetone.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.4 ml of 0.1% w/v suspension in acetone.
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4 ml of 0.1% w/v suspension in acetone.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. No with. + reactions: 20.0. Total no. in groups: 20.0.

Any other information on results incl. tables

The skin reactions after challenge applications were:

Test group - No dermal irritation in any animal;

Naive control group - Very slight erythema in two animals, no reaction in the other eight animals;

Vehicle control group - A very slight erythema in one animal, no reaction in the other nine animals;

Positive control group - Very slight to severe irritation in all 20 animals. The reaction in 19 animals exceeded the highest reaction observed in the naive positive control animals;

Naive positive control group - 5 of 20 animals exhibited very slight erythema, the other 15 animals had no skin reaction.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitising
Conclusions:
Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

0.4 ml undiluted test material was applied under an occlusive dressing to the shaved skin of 10 animals. Six hours after application, the dressing was removed and the skin wiped to remove residues of test material. The animals received one application each week for 3 weeks. 2 weeks following the third application a challenge dose (0.4 ml of a 1% solution in paraffin oil) was applied in the same manner as the sensitizing doses. A previously untreated site was used for the challenge application. Classification as a dermal sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.