C4-C10 branched and linear hydrocarbons (light) – Naphtha

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This endpoint has been reviewed, assessed and accepted by UK-HSE as competent authority for the notification of a new substance [EC number: 481-730-0; Data from UK-Notification Dossier by Shell U.K. Limited in accordance with Directive 92/32/EEC (Articles 7/8/9/12) O.J.L 154, Volume 35, 5 June 1992; Notification Report 06-31-0125-00 from 1st Nov, 2006].

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

Deviations: During the study period, the temperature of the animal room ranged from 21° to 24°C and the relative humidity ranged from 62 to 78%.
According to the OECD guideline 404 the temperature of the experimental animal room should be 20°C (± 3°C) and the relative humidity 30% to 70%. Both deviations are not considered to have an effect on the validity of the study.

GLP compliance:

yes

Remarks:

American Petroleum Institute

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): API-83-19, which is Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Substance type: test substance API-83-19 is a near analogue to Naphta (Fischer-Tropsch), light, C4-10 - branched and linear; it`s defined as:
'A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers
predominantly in the range of C7-C10 and boiling in the range 90-160°C (194-320°F).'
--> the test substance API 83-19 is comparable to 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear'

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Duration of treatment / exposure:

24 h

Observation period:

14 d

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 14 d

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 14 d

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 14 d

Score:

2.22

Max. score:

3

Reversibility:

not fully reversible within: 14 d

Other effects:

The test material produced slight to severe levels of irritation to the skin of rabbits as a result of 24-hour exposure. Blanching was seen within the
test sites of one animal at 96 hours. A possible necrotic area was seen at the test site of four animals at 7 days.
7 days after exposure, the dermal irritation score were 2 or higher in 4/5 animals. 14 days after exposure maximum 2/5 animals showed dermal
irritation score of 2 or more. No signs of ill health were seen during the study.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the test results and in conformity with the criteria given in Annex VI of the Directive, the test substance 'Naphtha (petroleum), light
alkylate' should be classified as 'irritating' --> 'Naphtha (Fischer-tropsch), light, C4-10 - branched and linear' should be also classified as
'irritating'.