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Diss Factsheets

Administrative data

Description of key information

Skin Sensitisation

C9-14 aliphatics (2-25% aromatics) were not dermal sensitizers using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406). Using read-across data from straight run kerosene, C14-C20 aliphatic, (2-30% aromatics) hydrocarbons fluids were determined not to be skin sensitizers using Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406).

Respiratory Sensitisation

no data

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 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 for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
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 chemical
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 chemical
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 vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
Justification for type of information:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Magnusson, B, and Kligman, AM, (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm., 52, 268-276.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test that followed sound scientific principles.
Species:
guinea pig
Strain:
other: P
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory, Breeding Unit
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
Route:
other: epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
No. of animals per dose:
10 males and 10 females were used in the exposure group
5 males and 5 females were used in the control group
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% w/v in corn oil
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% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% w/v in corn oil
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% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
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: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
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: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
other: Not specified

Skin Response After Challenge Procedure

Animal – Exposure Group

Immediate

24 hrs

48 hrs

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Male 6

-

-

-

Male 7

-

-

-

Male 8

-

-

-

Male 9

-

-

-

Male 10

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-

Female 6

-

-

-

Female 7

-

-

-

Female 8

-

-

-

Female 9

-

-

-

Female 10

-

-

-

Control Group

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-
Interpretation of results:
other: Not sensitising
Conclusions:
The test substance did not cause any skin response during the challenge procedure. The test substance is considered not sensitizing.
Executive summary:

This study examined the skin sensitization potential of Dilutene M5. Groups of 10 male and 10 female guinea pigs were induced with 0.1 % w/v of test substance in corn oil intradermally. 5 male and 5 female guinea pigs served as controls. The topical induction was performed with 50% w/v of test substance in corn oil. A topical challenge was then done with 25% w/v of test substance in corn oil. Animals were then scored for dermal reactions. No reaction was seen in any animal at any time during the experiment. The test substance is not sensitizing to skin.

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 conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no data available for Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, aromatics (2-30%). However, data is available for structural analogues, Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) and Kerosene. Petroleum substances of similar carbon number and aromatic content, principally kerosene and jet fuel, are typically in the range of C9-C16. These substances also contain similar types of molecules in similar proportions to those in C14-C20 aliphatic [2-30% Aromatics] Hydrocarbon solvents. In general, hydrocarbon solvents are more highly refined than petroleum substances. Accordingly, the petroleum substances typically represent a “worse case” with respect to hydrocarbon solvents and can be used for read across on that basis. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

A skin sensitization study (Shell, 1977a) performed according to Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406) found no indication of skin sensitization in guinea pigs for C9-14 aliphatics (2-25% aromatics).

Skin sensitization studies (API, 1985b) 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
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitization from Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) in laboratory animals or humans. However, skin sensitization studies utilizing C9-14 aliphatics (2-25% aromatics) and kerosene found no indication of skin sensitization in guinea pigs. With these observations, it is presumed that Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) will not be a respiratory sensitizing agent.


Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) does not meet the criteria for classification as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).