Registration Dossier

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: Standard method equivalent to EC method, GLP-compliant, adequate experimental details for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24hours instead 4 hours; occlusive conditions instead of semi-occlusive
Principles of method if other than guideline:
24h exposure dermal irritation test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:
0.5mL
Duration of treatment / exposure:
24 h
Observation period:
up to 14 days
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
1.8
Max. score:
2
Remarks on result:
other: Max. duration: 7 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
1.5
Max. score:
2.2
Remarks on result:
other: Max. duration: 7 d; Max. value at end of observation period: 0
Irritant / corrosive response data:
Slight to moderate erythema amd oedema seen after 24h gradually
resolved over 96h and barely perceptible reactions persisted
at 7 days. By 14 days scores were zero. Reversibility of any observed effect: Changes fully reversible within 14 days

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study on the analogous substance, Renewable Diesel is expected to be slightly irritating to skin by on significant enough to warrant classification within the EU.