Registration Dossier

Administrative data

Description of key information

There were no studies located for C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids.  Using read-across data from straight run kerosene, C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406).

C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids are not expected to be a respiratory sensitizing agent.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
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:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose:
read-across source
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.
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no data
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
0.4 ml of a 1% solution in paraffin oil
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.
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:

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.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization studies performed according to Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406) found no indication of skin sensitization in guinea pigs for straight run kerosene. Using this data as read across, C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406).

Respiratory sensitisation

Endpoint conclusion
Additional information:

There are no reports of respiratory sensitization from C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids in laboratory animals or humans.  However, C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406). It is presumed that C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids will not be a respiratory sensitizing agent.

Justification for classification or non-classification

These findings do not warrant the classification of C14-C20 aliphatic, 2-30% aromatic hydrocarbons fluids as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.