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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation

Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics was not a dermal sensitizer using read across 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:
1983/05/10-1983/06/06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According or similar to OECD Guideline 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)
Deviations:
yes
Remarks:
occlusive wrap used
GLP compliance:
yes
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:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Dutchland Laboratory Animals
Sex: Female (30)
Age at study initiation: 1-2 months
Weight at study initiation: 345- 461g
Housing: Individually
Diet (e.g. ad libitum): Purina Guinea Pig Chow (pellets), ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d

ENVIRONMENTAL CONDITIONS
Temperature (°F): 65-71
Humidity (%): 40-70%
Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 5.0% (v/v) in vehicle and 5.0% (v/v) in Freund's Complete Adjuvant (FCA) (diluted with an equal volume of water)
Dermal Application: 50.0% (occlusive dressing)
Topical challenge: 0.5 mL of 0.5% (v/v) in vehicle (max dose w/o producing visible irritation)
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 5.0% (v/v) in vehicle and 5.0% (v/v) in Freund's Complete Adjuvant (FCA) (diluted with an equal volume of water)
Dermal Application: 50.0% (occlusive dressing)
Topical challenge: 0.5 mL of 0.5% (v/v) in vehicle (max dose w/o producing visible irritation)
No. of animals per dose:
Control: Female (15)
Treatment: Female (15)
Details on study design:
Followed Magnusson and Kligman Guinea-Pig Maximization test (1969).
Briefly,
Day 0 – Induction of Sensitization by Intradermal Injection with and without adjuvant
A pair of 0.1 mL injections of the following solutions was intradermally administered to each of 3 sites in the clipped backs of the test animals. Site 1 –diluted FCA to both treated and control group; Site 2 – 5.0% MRD-83-205 in vehicle (treatment group) and undiluted vehicle (control group); Site 3 – 5.0% MRD-83-205 in diluted FCA (treatment group) and undiluted FCA (control group).

Day 7 – Induction by Occlusive Topical Application
0.5 mL of 50% MRD-83-205 (or vehicle for control animals) was topically applied over the injection sites on the shoulder of the treated group animal under an occlusive dressing for 48 hours.

Day 21 – Challenge by Occlusive Topical Application
0.5 mL of 0.5% MRD-83-205 in vehicle was topically applied to the animals under an occlusive dressing for 24 hours.

Animals were monitored for viability twice a day. Dermal reactions were scored according to the Draize methodology.

Challenge controls:
Vehicle controls were used for each of the induction treatments and for the challenge treatment.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
4
Total no. in group:
15
Clinical observations:
4 animals displayed an erythema score of 1
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: 4 animals displayed an erythema score of 1.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
5
Total no. in group:
15
Clinical observations:
5 animals displayed an erythema score of 1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 5.0. Total no. in groups: 15.0. Clinical observations: 5 animals displayed an erythema score of 1.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5% (v/v)
No. with + reactions:
4
Total no. in group:
15
Clinical observations:
3 animals displayed an erythema score of 1; one animal displayed an erythema score of 2
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5% (v/v). No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: 3 animals displayed an erythema score of 1; one animal displayed an erythema score of 2.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5% (v/v)
No. with + reactions:
4
Total no. in group:
15
Clinical observations:
4 animals displayed an erythema score of 1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5% (v/v). No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: 4 animals displayed an erythema score of 1.
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: Not sensitising
Conclusions:
Based on the scores of dermal irritation, test substance MRD-83-205 would not be considered a dermal sensitizer under the EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
Executive summary:

A Magnusson and Kligman Guinea-Pig Maximization test was conducted on 30 guinea pigs with MRD-83-205 . Following a preliminary irritation test, 15 guinea pigs were treated by intradermal injection (5.0% (v/v) vehicle or adjuvant/ MRD-83-205 ) to induce sensitization and then further sensitized by dermal application of 50.0% (v/v) MRD-83-205 . Guinea Pigs were challenged by topical application (0.5% (v/v) MRD-83-205 in corn oil). All animals survived to termination of study displaying an increase in weight over the initial values. There was a very low incidence of clinical in-life observations noted throughout the test period.  Following topical challenge with 0.5% MRD-83-205, four out of 15 animals in both the treated and control groups displayed minimal irritation. Based on the scores of dermal irritation, test substance MRD-83-205 would not be considered a dermal sensitizer under the EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.

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:
1983/05/10-1983/05/03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According or similar to OECD Guideline 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)
Deviations:
yes
Remarks:
occlusive wrap used
GLP compliance:
yes
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:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Dutchland Laboratory Animals
Sex: Female (30)
Age at study initiation: 1-2 months
Weight at study initiation: 360- 425g
Housing: Individually
Diet (e.g. ad libitum): Purina Guinea Pig Chow (pellets), ad libitum
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 22d

ENVIRONMENTAL CONDITIONS
Temperature (°F): 65-71
Humidity (%): 40-70%
Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 5.0% (v/v) in vehicle and 5.0% (v/v) in Freund's Complete Adjuvant (FCA) (diluted with an equal volume of water)
Dermal Application: 100.0% (occlusive dressing)
Topical challenge: 0.5% (v/v) in vehicle (max dose w/o producing visible irritation)
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection (sensitization; first phase): 5.0% (v/v) in vehicle and 5.0% (v/v) in Freund's Complete Adjuvant (FCA) (diluted with an equal volume of water)
Dermal Application: 100.0% (occlusive dressing)
Topical challenge: 0.5% (v/v) in vehicle (max dose w/o producing visible irritation)
No. of animals per dose:
Control: Female (15)
Treatment: Female (15)
Details on study design:
Followed Magnusson and Kligman Guinea-Pig Maximization test (1969).
Briefly,
Day 0 – Induction of Sensitization by Intradermal Injection with and without adjuvant
A pair of 0.1 mL injections of the following solutions was intradermally administered to each of 3 sites in the clipped backs of the test animals. Site 1 –diluted FCA to both treated and control group; Site 2 – 5.0% MRD-83-206 in vehicle (treatment group) and undiluted vehicle (control group); Site 3 – 5.0% MRD-83-206 in diluted FCA (treatment group) and undiluted FCA (control group).

Day 7 – Induction by Occlusive Topical Application
0.5 mL of neat MRD-83-206 (or vehicle for control animals) was topically applied over the injection sites on the shoulder of the treated group animal under an occlusive dressing for 48 hours.

Day 21 – Challenge by Occlusive Topical Application
0.5 mL of 0.5% MRD-83-206 in vehicle was topically applied to the animals under an occlusive dressing for 24 hours.

Animals were monitored for viability twice a day. Dermal reactions were scored according to the Draize methodology.

Challenge controls:
Vehicle controls were used for each of the induction treatments and for the challenge treatment.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
4
Total no. in group:
15
Clinical observations:
4 animals displayed an erythema score of 1
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: 4 animals displayed an erythema score of 1.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
4
Total no. in group:
15
Clinical observations:
4 animals displayed an erythema score of 1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: 4 animals displayed an erythema score of 1.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5% (v/v)
No. with + reactions:
4
Total no. in group:
15
Clinical observations:
3 animals displayed an erythema score of 1; one animal displayed an erythema score of 2
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5% (v/v). No with. + reactions: 4.0. Total no. in groups: 15.0. Clinical observations: 3 animals displayed an erythema score of 1; one animal displayed an erythema score of 2.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5% (v/v)
No. with + reactions:
3
Total no. in group:
15
Clinical observations:
3 animals displayed an erythema score of 1
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5% (v/v). No with. + reactions: 3.0. Total no. in groups: 15.0. Clinical observations: 3 animals displayed an erythema score of 1.
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: Not sensitising
Conclusions:
Based on the scores of dermal irritation, test substance MRD-83-206 would not be considered a dermal sensitizer under the EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
Executive summary:

A Magnusson and Kligman Guinea-Pig Maximization test was conducted on 30 guinea pigs with MRD-83-206. Following a preliminary irritation test, 15 guinea pigs were treated by intradermal injection (5.0% (v/v) vehicle or adjuvant/ MRD-83-206) to induce sensitization and then further sensitized by dermal application of 100.0% (v/v) MRD-83-206. Guinea Pigs were challenged by topical application (0.5% (v/v) MRD-83-206 in corn oil). All animals survived to termination of study displaying an increase in weight over the initial values.  There was a very low incidence of clinical in-life observations noted throughout the test period.  Following topical challenge with 0.5% MRD-83-206, four out of 15 animals in both the treated and control groups displayed minimal irritation.  Based on the scores of dermal irritation, test substance MRD-83-206 would not be considered a dermal sensitizer under the EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.

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: According or similar to OECD Guideline 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)
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 in animals available for Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics. However, data is available for structural analogues, Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics; Hydrocarbons, C10-C12, isoalkanes, <2% aromatics; Hydrocarbons, C10-C13, n-alkanes, <2% aromatics; and Hydrocarbons, C11-C14, n-alkanes, <2% aromatics and presented in the dossier. This data is read across to Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics 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 Magnusson and Kligman Guinea-Pig Maximization test (Shell, 1977) was conducted on 20 guinea pigs with the test material (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).

Hydrocarbons, C10-C13, n-alkanes, < 2% aromatics

 

A Magnusson and Kligman Guinea-Pig Maximization test was conducted on 30 guinea pigs with Hydrocarbons, C10-C13, n-alkanes, < 2% aromatics (ExxonMobil, 1983). Following a preliminary irritation test, 15 guinea pigs were treated by intradermal injection (5.0% (v/v) vehicle or adjuvant/ test material) to induce sensitization and then further sensitized by dermal application of 50.0% (v/v) test material. Guinea Pigs were challenged by topical application (0.5% (v/v) test material in corn oil). All animals survived to termination of study displaying an increase in weight over the initial values. There was a very low incidence of clinical in-life observations noted throughout the test period. Following topical challenge with 0.5% Hydrocarbons, C10-C13, n-alkanes, < 2% aromatics, four out of 15 animals in both the treated and control groups displayed minimal irritation. Based on the scores of dermal irritation, test substance would not be considered a dermal sensitizer under the EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.

 

Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics

 

A Magnusson and Kligman Guinea-Pig Maximization test was conducted on 30 guinea pigs with Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics (ExxonMobil, 1983). Following a preliminary irritation test, 15 guinea pigs were treated by intradermal injection (5.0% (v/v) vehicle or adjuvant/ test material) to induce sensitization and then further sensitized by dermal application of 100.0% (v/v) test material. Guinea Pigs were challenged by topical application (0.5% (v/v) test material in corn oil). All animals survived to termination of study displaying an increase in weight over the initial values. There was a very low incidence of clinical in-life observations noted throughout the test period. Following topical challenge with 0.5% Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics, four out of 15 animals in both the treated and control groups displayed minimal irritation. Based on the scores of dermal irritation, test substance would not be considered a dermal sensitizer under the EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.

Human Data

 

Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2%aromatics

 

A study (ExxonMobil, 1991) was conducted to determine the potential of the test material (Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2%aromatics) to cause dermal irritation and sensitization in humans. 118 humans were exposed to the test material. Induction applications (0.1 ml test material, neat) were made to the arm for 24 hours under a semi-occlusive patch. Sixty-one subjects exhibited strong cutaneous reactions consisting of strong erythema/edema, papules, and vesicular responses to test substance at the first induction evaluation. The evaluation of this sample was discontinued on July 26, 1991 by the Test Operations Supervisor and the Investigator due to this strong reaction. The overall response patterns (induction, challenge, and rechallenge) to Hydrocarbons, C9-C11, n-alkanes, isoalkanes, cyclics, <2% aromatics are consistent with a severe clinical irritant.

 

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

 

A study (ExxonMobil, 1988a) was conducted to determine the potential of the test material (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. The test material showed no evidence of being a photocontact 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.

 

A study (ExxonMobil, 1988b) was conducted to determine the potential of the test material (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 the 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.

 

Hydrocarbons, C10-C12, isoalkanes, < 2% aromatics and Hydrocarbons, C11-C12, isoalkanes, <2% aromatics

 

MRD-61-24, MRD-61-25, and MRD-61-50 were evaluated for skin irritating properties in humans following a simulated use patch technique (ExxonMobil, 1962). 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 MRD-61-24, MRD-61-25, and MRD-61-50 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 from Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics in laboratory animals or humans. However, skin sensitization studies utilizing structural analogues found no indication of skin sensitization in guinea pigs. Moreover, in studies on human volunteers using Hydrocarbons, C10-C12, isoalkanes, <2% aromatics, there were no signs of irritation or sensitization effects of the test substances. With these observations, it is presumed that C9-C11, isoalkanes, cyclics, <2% aromatics will not be a respiratory sensitizing agent.

Justification for classification or non-classification

Based on the weight of evidence from available read across data (Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406)), Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics is not considered to be a skin sensitizer.

These findings do not warrant the classification of Hydrocarbons, C9-C11, isoalkanes, cyclics, <2% aromatics as a skin or respiratory sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).