Naphtha (petroleum), hydrodesulfurized heavy, co-processed with hydrocarbons derived from thermally cracked waste plastics

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report similar or equivalent to OECD 406. GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

The available Buehler test provides information on skin sensitisation potential by measuring challenge-induced dermal hypersensitivity reactions elicited in test animals compared with controls.

Species:

guinea pig

Strain:

Hartley

Sex:

male

Route:

epicutaneous, occlusive

Vehicle:

other: mineral oil

Concentration / amount:

Induction dose: 0.5 ml, neat
Challenge dose: 0.5 ml, 1:2 dilution in mineral oil

Positive Control DNCB:
Induction/Challenge: 0.05% DNCB in ethanol

Route:

epicutaneous, occlusive

Vehicle:

other: mineral oil

Concentration / amount:

Induction dose: 0.5 ml, neat
Challenge dose: 0.5 ml, 1:2 dilution in mineral oil

Positive Control DNCB:
Induction/Challenge: 0.05% DNCB in ethanol

No. of animals per dose:

10 males for induction/challenge

Details on study design:

A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Frequency of applications: three times per week
- Duration: 3 weeks


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 14 post-induction application
- Exposure period: 6 hours
- Evaluation (hr after challenge): 24 and 48 hr

OTHER: response grade score = erythema + edema

Challenge controls:

Naive guinea pigs receiving only the challenge dose in order to distinguish between “background” irritation response and actual allergenic response.

Positive control results:

Most of the positive control group animals showed evidence of sensitization.

Key result

Group:

test chemical

Remarks on result:

no indication of skin sensitisation

Group:

positive control

Remarks on result:

positive indication of skin sensitisation

Group:

negative control

Remarks on result:

other: Negative control scores not specified

Since the challenge treatment did not produce scores higher than the sensitizing treatment, the test substance was considered to be non-sensitizing.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Unleaded motor gasoline (API PS-6) did not induce a sensitisation response in guinea pigs in this study. This finding does not warrant the classification of the test article as a skin sensitiser under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Executive summary:

Male Hartley Albino guinea pigs were dermally exposed to unleaded motor gasoline (API PS-6), neat, at a volume of 0.5 ml for each of the three induction phases. For the challenge phase, unleaded motor gasoline was administered as a 1:2 dilution in mineral oil for the challenge and challenge control group animals. Response grades, severity and incidence at the time of the challenge exposure for the test article indicated no dermal responsiveness in the induction/challenge group above that observed in the naive challenge control group.

For the positive control group, response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group.

This finding does not warrant the classification of unleaded motor gasoline (API PS-6) as a skin sensitiser under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a read-across sensitisation study with gasoline, there was no evidence of dermal sensitization in a Buehler test in guinea pigs

Migrated from Short description of key information:

Skin sensitization – Not sensitizing in guinea pig (OECD TG 406).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In a read-across guinea pig sensitisation study with gasoline there was no evidence of dermal sensitisation. Thus, the data available do not support classification as a sensitiser according to EU CLP Regulation (EC No. 1272/2008).