Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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).