Butyl propionate

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.