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Administrative data

Description of key information

Skin sensitisation

Hydrocarbons, C10-C13, aromatics, >1% naphthalene was not a dermal sensitizer using a read across Magnusson and Kligman Guinea-Pig Maximization test (OECD 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:
1983/05/10-1983/05/03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According or similar to OECD Guideline 406.
Justification for type of information:
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:
no
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Scientifically valid guinea pig maximisation test
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 chemical
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 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.
Key result
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.
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).
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).

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 human data available for Hydrocarbons, C10-C13, aromatics, >1% naphthalene. This data is supported by information available for a structural analogue, Hydrocarbons, C10, aromatics, >1% naphthalene. This data is read across to Hydrocarbons, C10 -C13, aromatics, >1% naphthalene based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Skin Sensitisation

 

Hydrocarbons, C10, aromatics, >1% naphthalene

 

A Magnusson and Kligman Guinea-Pig Maximization test (Shell, 1977) was conducted on 30 guinea pigs with the test material (Hydrocarbons, C10, aromatics, >1% naphthalene). Following a preliminary irritation test, 20 guinea pigs were treated by intradermal injection (0.05% (w/v) vehicle/test material) to induce sensitization and then further sensitized by dermal application of 50.0% (w/v) test material in corn oil. Guinea Pigs were challenged by topical application (25.0% (w/v) test material 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).

Moreover, in studies on human volunteers using Hydrocarbons, C10, aromatics, >1% naphthalene and Hydrocarbons, C10-C13, aromatics, >1% naphthalene, there were no signs of irritation or sensitization effects of the test substances.

 

Hydrocarbons, C10, aromatics, >1% naphthalene

 

In a key study (ExxonMobil, 1987), the test material (Hydrocarbons, C10, aromatics, >1% naphthalene) was evaluated for its ability to cause dermal irritation and sensitization in a 26 person Human Patch Test.  In addition, the ability to induce a phototoxic or photo contact response was determined by comparing irradiated and non-irradiated skin sites. The test material was applied to the skin of human volunteers under semi-occlusive dressing. Dermal examinations occurred after exposures (day 1 and day 2) and at 24-, 48, and 72-hours post exposure. Dermal irritation and damage was assessed and scored according to a modified Draize scale. 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-C13, aromatics, >1% naphthalene

 

A key study (ExxonMobil, 1987) was conducted to determine the potential of the test material (Hydrocarbons, C10-C13, aromatics, >1% naphthalene) 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. Hydrocarbons, C10-C13, aromatics, >1% naphthalene 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 photo contact allergen and no evidence of being either a primary irritant or a contact allergen. Based on these data and results, Hydrocarbons, C10-C13, aromatics, >1% naphthalene would not be classified as a dermal irritant or as a dermal sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitization from Hydrocarbons, C10-C13, aromatics, >1% naphthalene in laboratory animals or humans. However, a read across skin sensitization study utilizing hydrocarbons, C10, aromatics, >1% naphthalene 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, C10-C13, aromatics, >1% naphthalene will not be a respiratory sensitizing agent.

Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C10-C13, aromatics, >1% naphthalene 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).