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Diss Factsheets

Administrative data

Description of key information

Based on available read across data (Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406)), Hydrocarbons, C11-C13, isoalkanes, <2% aromatics is not considered to be a skin sensitizer. Hydrocarbons, C11-C13, isoalkanes, <2% aromatics is not considered to be a skin sensitizer based on read across data available from Human Repeated Insult Patch Tests (HRIPT).

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:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According or similar to OECD Guideline 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 for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
occlusive wrap used
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 Strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Shell Toxicology Laboratory, Breeding Unit.
Sex: Female (10) and Male (10); Controls: Males (5); Males (5)
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 1.0% (w/v) in vehicle
Topical Induction: 50.0% w/v (occlusive dressing)
Challenge dose: 25% w/v
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 1.0% (w/v) in vehicle
Topical Induction: 50.0% w/v (occlusive dressing)
Challenge dose: 25% w/v
No. of animals per dose:
Control: Male (5); Female (5)
Treatment: Female (10); Male (10)
Details on study design:
Followed Magnusson and Kligman Guinea-Pig Maximization test (1969).
Challenge controls:
Vehicle controls were used for each of the induction treatments and for the challenge treatment.
Positive control substance(s):
no
Reading:
other: immediately after challenge
Hours after challenge:
0
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: immediately after challenge. . Hours after challenge: 0.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
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.
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.
Reading:
other: immediately after challenge
Hours after challenge:
0
Group:
test chemical
Dose level:
25.0% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: immediately after challenge. . Hours after challenge: 0.0. Group: test group. Dose level: 25.0% w/v . No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25.0% w/v
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: 25.0% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25.0% w/v
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: 25.0% w/v . No with. + reactions: 0.0. Total no. in groups: 20.0.
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: Not sensitising
Conclusions:
Classification as a skin sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

A Magnusson and Kligman Guinea-Pig Maximization test was conducted on 20 guinea pigs with Shellsol TD. Twenty guinea pigs were treated by intradermal injection (1.0% (w/v) Shellsol TD in vehicle) to induce sensitization and then further sensitized by dermal application of 50.0% (w/v) Shellsol TD. Guinea Pigs were challenged by topical application (25.0% (w/v) Shellsol TD in corn oil). All animals survived to termination of study.  There was a very low incidence of clinical in-life observations noted throughout the test period.  Following topical challenge with 25.0% (w/v) Shellsol TD, all animals were free of dermal irritation.  Classification as a skin sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/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:

There is no data available for Hydrocarbons, C11-C13, isoalkanes, <2% aromatics. However, data is available for structural analogue, Hydrocarbons, C10-C12, isoalkanes, <2% aromatics. 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.

Hydrocarbons, C10-C12, isoalkanes, <2% aromatics

A key Magnusson and Kligman Guinea-Pig Maximization test (Shell, 1977) was conducted on 20 guinea pigs with Hydrocarbons, C10-C12, isoalkanes, <2% aromatics. Twenty guinea pigs were treated by intradermal injection (1.0% (w/v) test material in vehicle) to induce sensitization and then further sensitized by dermal application of 50.0% (w/v) test material. Guinea Pigs were challenged by topical application (25.0% (w/v) test material in corn oil). All animals survived to termination of study.  There was a very low incidence of clinical in-life observations noted throughout the test period.  Following topical challenge with 25.0% (w/v) test material, all animals were free of dermal irritation. Classification as a skin sensitizer is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

A key human skin patch test (ExxonMobil Corp, 1988c) was conducted to determine the potential of Hydrocarbons, C10-C12, isoalkanes, <2% aromatics to cause dermal irritation and sensitization in humans with or without UV irradiation. Twenty-eight humans were exposed to the test material. Dermal examinations occurred after exposures (day 1 and day 2) and then at 24h, 48h, and 72h post exposure. Dermal irritation and damage was assessed and scored according to a modified Draize scale. The most severe reaction noted in all experimental paradigms was noted as a "1" or slight erythema. The test material did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. MRD-88-296 showed no evidence of being a photo contact allergen and no evidence of being either a primary irritant or a contact allergen. Based on these data and results, Hydrocarbons, C10-C12, isoalkanes, <2% aromatics would not be classified as a dermal irritant or as a dermal sensitizer.

Another key human skin patch test (ExxonMobil Corp, 1988d) was conducted to determine the potential of Hydrocarbons, C10-C12, isoalkanes, <2% aromatics to cause dermal irritation and sensitization in humans. The induction applications were made to a site on the back (0.2 ml test material, neat) using an occlusive patch.  The patch held the material in place for 24 hours at which time, the subjects returned for an evaluation of the application site and for new test material to be applied.  Due to 35 subjects developing an erythema score between 3 and 5, it was decided that a 50/50 w/w test sample (in USP petrolatum) would be applied to an alternate test site using a semi-occlusive patch for the duration of the experiment after subjects were treatment-free for one week.  Applications were held in place via a semi-occlusive patch for 24 hours and subjects were examined daily for dermal effects before receiving a fresh application of 50/50 w/w test material for a total of 9 additional applications.  A 3-5 day rest period followed the last induction application.   A challenge application was applied to a naïve site on the back that consisted of a 50% (w/w) of test material preparation held in place by a semi-occlusive patch for a total of 4- 24 hour applications. 

There was no indication that the test material possesses a skin-sensitizing propensity as there was no recordable skin irritation noted in any of the patients.  When the test material, neat was applied under occluded conditions, the severe irritation that occurred indicates that it would be considered a dermal irritant.  However, the occlusion of the test material prevents evaporation and changes the permeability of the dermis.  In order to determine the irritancy of the test material in a relevant paradigm, a 50% (w/w) solution of the test material was applied under a semi-occluded patch.  No significant dermal irritation was noted and thus, Hydrocarbons, C10-C12, isoalkanes, <2% aromatics would not be considered a dermal irritant.

In a third key study (ExxonMobil Corp., 1962e), Hydrocarbons, C10–C12, isoalkanes, < 2% aromatics and Hydrocarbons, C11–C12, isoalkanes, < 2% aromatics were evaluated for skin irritating properties in humans following a simulated use patch technique. A total of 101 subjects, including males and females, participated in the program. Each subject was patch tested before and after a three-week simulated use period. Under conditions and procedures used in the investigation the test materials will not be considered primary skin irritants under semi-occluded conditions. None of the test materials produced skin fatigue on repeated daily application during a three-week simulated use period. None of the test materials were skin sensitizers.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitization for Hydrocarbons, C11-C13, isoalkanes, <2% aromatics in laboratory animals or humans.  However, skin sensitization studies utilizing structural analogues found no indication of skin sensitization in guinea pigs.  Additional studies in humans also found no indication of skin sensitization. With these observations, it is presumed that Hydrocarbons, C11-C13, isoalkanes, <2% aromatics will not be respiratory sensitizers.

Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C11-C13, isoalkanes, <2% aromatics do not meet the criteria for classification as skin or respiratory sensitizers under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).