Naphtha (petroleum), light straight-run, co-processed with hydrocarbons derived from thermally cracked waste plastics

Skin sensitisation

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

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.

Test material

Test material information

Constituent 1

Reference substance name:

Gasoline

EC Number:

289-220-8

EC Name:

Gasoline

Cas Number:

86290-81-5

Constituent 2

Reference substance name:

unleaded gasoline

IUPAC Name:

unleaded gasoline

Constituent 3

Reference substance name:

PS-6

IUPAC Name:

PS-6

Test material form:

other: low viscosity liquid hydrocarbon

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: mineral oil

Induction 2

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

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: mineral oil

Challenge 2

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.

Results and discussion

Positive control results:

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

In vivo (non-LLNA)

Results

Results 1

Key result

Group:

test chemical

Remarks on result:

no indication of skin sensitisation

Results 2

Group:

positive control

Remarks on result:

positive indication of skin sensitisation

Results 3

Group:

negative control

Remarks on result:

other: Negative control scores not specified

Any other information on results incl. tables

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

Applicant's summary and conclusion

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).