Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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 methodolgy followed was equivalent or similar to OECD TG 405 and the report contains sufficient information to permit a meaningful evaluation of study results

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
not applicable
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl propionate
EC Number:
209-669-5
EC Name:
Butyl propionate
Cas Number:
590-01-2
Molecular formula:
C7H14O2
IUPAC Name:
butyl propanoate
Details on test material:
- Name of test material (as cited in study report): UCAR n-butyl propionate
- Physical state: clear clolourless low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: 51-18
- Stability under test conditions: yes
- 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: assumed to be in-house
- Age at study initiation: adults
- Weight at study initiation: no information available
- Housing: assumed to be housed individually
- Diet (e.g. ad libitum): ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Post instillation of 0.1 ml into the lower conjuctival sac of one eye per animal, both the eyelids are held together for 1 second
Observation period (in vivo):
1 hour, 4 hours, 1 day, 2 days, 3 days and 7 days post dosing with additional readings taken on 14 and 21 days if needed
Number of animals or in vitro replicates:
6 rabbits (4 males + 2 females)
Details on study design:
Post instillation of 0.1 ml of UCAR n-butyl propionate into the lower conjuctival sac of one eye per animal, both the eyelids are held together for 1 second and eye reactions noted at 1 hour, 4 hours, 1 day, 2 days, 3 days and 7 days post dosing with additional readings taken on 14 and 21 days 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:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible
Remarks:
72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Instillation of 0.1 ml of sample into rabbit eyes resulted in no corneal injury (opacity) in any of 6 animals. Transient iritis was apparent in 2 eyes and minor to moderate conjunctival irritation developed in 6 rabbits within one hour. A substantial amount of discharge was noted in each eye. After 24 hours, only minor conjunctival redness remained in all rabbits. By 48 hours, 5 eyes had a normal appearance. All 6 eyes were healed after 72 hours.
Other effects:
Fluorescein examination of the eyes revealed no changes.

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 and as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for eye irritation.
Executive summary:

In this eye irritation study, UCAR n-butyl propionate was instilled into the eyes of 6 rabbits. 0.1 ml was instilled into the lower conjuctival sac of one eye per animal, both the eyelids held together for 1 second and eye reactions noted at 1 hour, 4 hours, 1 day, 2 days, 3 days and 7 days post dosing with additional readings taken on 14 and 21 days if needed. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.

Instillation of 0.1 ml of sample into rabbit eyes resulted in no corneal injury (opacity) in any of 6 animals. Transient iritis was apparent in 2 eyes and minor to moderate conjunctival irritation developed in 6 rabbits within one hour. A substantial amount of discharge was noted in each eye. After 24 hours, only minor conjunctival redness remained in all rabbits. By 48 hours, 5 eyes had a normal appearance. All 6 eyes were healed after 72 hours.

Under the conditions of the study and as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for eye irritation.