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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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
Remarks:
, see "Principles of method if other than guideline"
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

Test material

Constituent 1
Reference substance name:
Naphtha (petroleum), light alkylate
EC Number:
265-068-8
EC Name:
Naphtha (petroleum), light alkylate
Cas Number:
64741-66-8
IUPAC Name:
Naphtha (petroleum), light alkylate
Details on test material:
- Name of test material (as cited in study report): Naphtha (petroleum), light alkylate [CAS 64741-66-8]
- Test substance is closely related to Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear; it is 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).'

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
24 h
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
other: 96 h
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
14 d
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
24 h
Score:
1.5
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
other: 96 h
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 14 d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
7 d
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
14 d
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14d (5/6 animals)
Remarks on result:
other: treatment on abraded area
Irritant / corrosive response data:
all individual dermal irritation scores i.a. for treatment on intact area: see 'Attached Background material'
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. No signs of ill health were seen during the study.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
On the basis of the test results and in conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' should be classified as 'irritating'.
Executive summary:

A dermal irritation study in rabbits was performed (similar to OECD Guideline 404) on 'Light-alkylated Naphtha' (CAS 64741-66-8).

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.

On the basis of the test results and in conformity with EU GHS, the test substance 'Naphtha (petroleum), light alkylate' should be classified as 'irritating' (skin irrit. 2; H315).