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Administrative data

Description of key information

Skin Sensitisation

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

 

Hydrocarbons, C9 Aromatics:

Hydrocarbons, C9 Aromatics were negative using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406). Hydrocarbons, C9 Aromatics were negative in a Human Repeated Insult Patch Test (HRIPT).

 

Hydrocarbons, C10-C12 Aromatics:

C10-C12 Aromatics were negative using a Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406). C10-C12 Aromatics were negative in a Human Repeated Insult Patch Test (HRIPT).

Respiratory Sensitisation

No data available

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:
1983/05/10-1983/05/03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 406.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
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:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Dutchland, Inc.
- Sex: Female (30)
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: 352-437 g
- 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: 22 days


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-71
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: Primol 185 (injection); neat (dermal application)
Concentration / amount:
Intradermal injection (max. tolerated dose: 5.0% (w/v) FCA (adjuvant)/MRD-83-208 and 5.0% (w/v) vehicle/MRD-83-208
Dermal Application: neat
Route:
epicutaneous, occlusive
Vehicle:
other: Primol 185 (injection); neat (dermal application)
Concentration / amount:
Intradermal injection (max. tolerated dose: 5.0% (w/v) FCA (adjuvant)/MRD-83-208 and 5.0% (w/v) vehicle/MRD-83-208
Dermal Application: neat
No. of animals per dose:
Control: Female (15)
Treatment: Female (15)
Details on study design:
INDUCTION EXPOSURE

INTRADERMAL INJECTION (DAY 0)
Site: 3 injections (0.1 ml/injection) on both sides of the spinal cord for a total of 6 paired injections
- Site 1: diluted FCA to both treated and control groups
- Site 2: 5.0% MRD-83-208 diluted in vehicle; and undiluted vehicle to control animals
- Site 3: Concentration: 5.0% MRD-83-208 in diluted FCA (adjuvant); and 5.0% vehicle in diluted FCA to the control group

INDUCTION BY OCCLUSIVE TOPICAL APPLICATION (DAY 7)
Experimental animals received 0.5 ml neat MRD-83-208 over the injection site under an occlusive wrap and held in place for 48 hrs. Control animals received 0.5 ml vehicle.

CHALLENGE EXPOSURE
Animals were challenged with either 0.5 ml 0.5% MRD-83-208 in vehicle or just vehicle (control group) that was topically applied to the clipped area on the right flank under an occlusive wrap for 24 hrs.

EXPERIMENTAL EVALUATION
Observations for toxicological signs occured immediately after dosing on day 0, 7, 10, 14, 21, and each time dermal observations were made. Body weights were recorded on days 0, 7, 14, 21, and at sacrifice. Dermal evaluations occured 24 hrs after the induction patch was removed (day 10) and 24 and 48 hrs after removal of the challenge patch. Dermal responses were evaluated by the Draize Method.
Challenge controls:
Vehicle controls were used for each of the induction treatments and for the challenge treatment.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
8
Total no. in group:
15
Clinical observations:
Slight erythema (score of 1 for all + animals)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 15.0. Clinical observations: Slight erythema (score of 1 for all + animals).
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
7
Total no. in group:
15
Clinical observations:
slight erythema (score of 1 for all + animals)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5%
No. with + reactions:
10
Total no. in group:
15
Clinical observations:
slight erythema (score of 1 for all + animals except one that scored 2)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 10.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals except one that scored 2).
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5%
No. with + reactions:
7
Total no. in group:
15
Clinical observations:
slight erythema (score of 1 for all + animals)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 7.0. Total no. in groups: 15.0. Clinical observations: slight erythema (score of 1 for all + animals).
Key result
Group:
positive control
Remarks on result:
not measured/tested

Summary of other skin sensitisation studies

End Point Study Reference  
REACH requirement IUCLID Section Study Name Data Waiving Waiving Justification Species Study Result Type Test Guideline/Qualifier Test Guideline/Guideline Test Guideline/Deviations Reliability Rational For Reliability GLP Compliance Test Materials/Identity Study Result Reference Type Reference Author Reference Year Reference Title Bibliographic Source Testing Laboratory Reference Report No. Owner Company Company Study No. Report Date Data access
8.3 Skin sensitization 7.4.1 Skin Sensitization guinea pig Experimental result Equivalent or similar to  Magnusson, B., and Kligman, A.M., (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Derm.,52, 268-276. 2 Summary only of study. No data     Shellsol A not sensitizing Study report Coombs, AD, Blair, D, Doak, SM, Carter, BI 1977 The Acute Toxicity of Shellsol A HSPA0687 Sittingbourne Research Centre M(T)-1-77 Shell Chemicals Europe BV June, 1977 yes
Interpretation of results:
other: Not sensitising
Conclusions:
Based on the scores of dermal irritation, test substance would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
Executive summary:

A Hartley dermal sensitization test was conducted on 30 guinea pigs. Following a preliminary irritation test, 15 Hartley guinea pigs were treated by intradermal injection (0.01 mL; 5.0% (w/v) vehicle/MRD-83 -208 or with adjuvant) to induce sensitization and then further sensitized by dermal application of 0.5 ml MRD-83 -208 a week after the intradermal injection. Guinea pigs were challenged two weeks later by topical application (0.5 ml 0.5% MRD-83 -208).

No indication of sensitization was noted.

Based on the scored of dermal irritation, test substance MRD-83 -208 would not be considered a dermal sensitizer under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
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.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
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:
female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Shell Toxicology Laboratory, Breeding Unit
Sex: Male (15); Female (15)
Age at study initiation: Approximately 7 weeks
Weight at study initiation: 352- 437g
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: 0.05% (w/v) Shellsol AB in corn oil
Dermal Application: 50.0% (w/v) Shellsol AB in corn oil
Topical challenge: 25.0% (w/v) Shellsol AB in corn oil
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Intradermal Injection: 0.05% (w/v) Shellsol AB in corn oil
Dermal Application: 50.0% (w/v) Shellsol AB in corn oil
Topical challenge: 25.0% (w/v) Shellsol AB in corn oil
No. of animals per dose:
Control: Male (5); Female (5)
Treatment: Male (10); Female (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
Key result
Reading:
other: Immediate
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: Immediate. . Hours after challenge: 0.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
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.
Key result
Reading:
other: Immediate
Hours after challenge:
0
Group:
test group
Dose level:
25.0% (w/v)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: Immediate. . 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.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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.
Key result
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: Not sensitising
Conclusions:
Classification as an 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:

A Magnusson and Kligman Guinea-Pig Maximization test was conducted on 30 guinea pigs with Shellsol AB. Following a preliminary irritation test, 20 guinea pigs were treated by intradermal injection (0.05% (w/v) vehicle/Shellsol AB) to induce sensitization and then further sensitized by dermal application of 50.0% (w/v) Shellsol AB in corn oil. Guinea Pigs were challenged by topical application (25.0% (w/v) Shellsol AB in corn oil).

No indication of sensitization was noted.

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

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

 

Hydrocarbons, C9 Aromatics:

 

A skin sensitization study performed according to Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406) found no indication of skin sensitization in guinea pigs for Hydrocarbons, C9 aromatics. Hydrocarbons, C9 aromatics are not skin sensitizers or photosensitizers in humans. Hydrocarbons, C9 Aromatics were evaluated for its ability to induce skin sensitization in a 26 person Human Repeated Insult Patch Test (HRIPT). In addition, the ability to induce a phototoxic or photocontact response was determined by comparing irradiated and non-irradiated skin sites. Application to the skin without or in conjunction with UV irradiation did not elicit a sensitizing or photosensitizing response in any of the study participants.

 

Hydrocarbons, C10-C12 Aromatics:

A skin sensitization study performed according to Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406) found no indication of skin sensitization in guinea pigs for C10-C12 Aromatics. C10-C12 Aromatics are not skin sensitizers or photosensitizers in humans. C10-C12 Aromatics were evaluated for its ability to induce skin sensitization in a 100+ person Human Repeated Insult Patch Test (HRIPT). In addition, the ability to induce a phototoxic or photocontact response was determined by comparing irradiated and non-irradiated skin sites. C10-C12 Aromatics were applied to the skin of human volunteers under semi-occlusive dressing as a 30% w/w concentration in petrolatum. Application to the skin without or in conjunction with UV irradiation did not elicit a sensitizing or photosensitizing response in any of the study participants.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.

 

Hydrocarbons, C9 Aromatics:

There are no reports of respiratory sensitization from C9 Aromatics in laboratory animals or humans. A skin sensitization study utilizing C9 Aromatics 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 C9 Aromatics will not be a respiratory sensitizing agent.

 

Hydrocarbons, C10-C12 Aromatics:

There are no reports of respiratory sensitization from C10-C12 Aromatics in laboratory animals or humans. However, a skin sensitization study utilizing C10-C12 Aromatics 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 C10-C12 Aromatics will not be a respiratory sensitizing agent.

Justification for classification or non-classification

There is no data available for Hydrocarbons, C9-C10, aromatics, >1% Naphthalene. Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Based on available read across data, Hydrocarbons, C9-C10, aromatics, >1% Naphthalene do not warrant classification as a skin or respiratory sensitizer under Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).