Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
EC Number:
204-793-6
EC Name:
2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
Cas Number:
126-57-8
Molecular formula:
C33H62O6
IUPAC Name:
2,2-bis[(nonanoyloxy)methyl]butyl nonanoate (non-preferred name)
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The eye of each animal treated with the anaesthetic but not with the test item served as control.
Duration of treatment / exposure:
Animals were dosed once only on the day of dosing (Day 1). Each animal was treated with 0.1 mL aliquot of the test item onto the right eye.
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after the end of dosing.
Number of animals or in vitro replicates:
3 animals/group

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h post-dose observation.
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
The read-across application is justified in the analogue justification. Based on the available data, the target and source substances are considered to be unlikely to show differences in eye irritancy potential. These results indicate that the test item, Trimethylolpropane Tripelargonate, has no relevant irritating effect on the eye of the rabbit.
Executive summary:

The acute eye irritation of Trimethylolpropane Tripelargonate was investigated in rabbits. A 0.1 mL aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed approximately 1, 24, 48, and 72 hours after dosing. No significant irritation at either the conjunctivae, iris or cornea was recorded in any treated animal during the study. There were no signs of pain/distress after dosing. Changes in body weight were not remarkable. There was no indication of a systemic effect related to treatment. These results indicate that the test item, Trimethylolpropane Tripelargonate, has no relevant effect on the eye of the rabbit.