Registration Dossier

Administrative data

Endpoint:
eye 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.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
GLP-compliant test, believed to be broadly comparable to the
old version of EC B5. In 3 additional rabbits, eyes were
flushed with water 20-30 secs after treatement. Irritation
was scored at 1, 24, 72 and 96h and 7 days. Scores were
combined using the Draize system.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Nature of substance: Undiluted liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
test material in instilled in eye for 20-30 seconds then flushed with water
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
No corneal or iridial irritation was seen and there was no
initial pain response. At 24h minor irritation (mean score
0) was seen in unwashed eyes: this had gone by 48h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information 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.