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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near-guideline, GLP-compliant study. Adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: viscous hydrocarbon liquid
Details on test material:
No. 6 Heavy Fuel Oil (API 78-6 with Specific Gravity 0.99/2.7%S),Fuel oil No. 6, CAS No. 68553-00-4.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hour(s)
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.35
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.17
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.17
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.17
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0.08
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin

Any other information on results incl. tables

A mean primary dermal irritation index of 0.35 out of a maximum score of 8.0 indicated that the test substance was minimally irritating.  The mean erythema score for the intact skin was 0.25, and the mean oedema score was also 0.25.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Application of the material to the clipped skin of rabbits under occlusive patch for 24 hrs did not result in significant dermal irritation.
Executive summary:

The material was applied to the clipped skin of three male and three female New Zealand White rabbits for 24 hours. 0.5 mL of test substance was applied to both abraded and non-abraded skin areas and covering with a closed patch. The animals were monitored over 72 hours post exposure and scored according to the Draize scale. Significant irritation was not observed following treatment.