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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent to OECD TG 405 and the report contains sufficient information to permit a meaningful evaluation of study results
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): UCAR N-pentyl propionate
- Molecular weight: 144.2
- Physical state: clear colourless, low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: BRRC Sample No. 51-19
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 2.0-3.0 kg
- Housing: group housed
- Diet (e.g. ad libitum): appropriate commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml undiluted UCAR n-pentyl propionate
Duration of treatment / exposure:
approximately one second
Observation period (in vivo):
1 hour, approximately 4 hours, 1 day, 2 days, 3 days and 7 days with additional readings on 14 days and 21 days, if needed
Number of animals or in vitro replicates:
4 male + 2 female
Details on study design:
0.1 ml of UCAR n-pentyl propionate (undiluted) was instilled into the lower conjunctival sac of one eye of 6 New Zealand White rabbits and the eyelids held together about 1 second. The eyes were scored as per Draize method at 1 hour, 4 hours, 1 day, 2 days, 3 days and 7 days after dosing. Additional readings were done on days 14 and 21, if needed. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
There were no signs of eye irritation in the tested rabbits
Other effects:
not applicable

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, UCAR n-pentyl propionate would not be be classified as an eye irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures
Executive summary:

In this study, the eye irritation potential of undiluted UCAR n-pentyl propionate was evaluated on four male and two female New Zealand White rabbits.

0.1 ml of UCAR n-pentyl propionate (undiluted) was instilled into the lower conjunctival sac of one eye of 6 New Zealand White rabbits and the eyelids held together about 1 second. The eyes were scored as per Draize method at 1 hour, 4 hours, 1 day, 2 days, 3 days and 7 days after dosing. Additional readings were done on days 14 and 21, if needed. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day. There were no signs of eye irritation in the tested rabbits. Under the conditions of the study, UCAR n-pentyl propionate would not be be classified as an eye irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.