N-butyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well described study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize method

Principles of method if other than guideline:

Three male and three female New Zealand White rabbits were dosed with either 0.1 or 0.005 ml of n-butyl acetate directly onto the eye. The eyelid was held together for one second. The eyes were scored by the Draize method at one and four hours, and 1, 2, 3, and 7 days after dosing. At the Day 1 observation time point, fluorescein staining was used to detect corneal injury.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl acetate

EC Number:

204-658-1

EC Name:

N-butyl acetate

Cas Number:

123-86-4

Molecular formula:

C6H12O2

IUPAC Name:

butyl acetate

Details on test material:

n-butyl acetate. Analytical data available but not included in available records. Commercial Sample used in testing (99.6 % Purity).

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three male and three female New Zealand White rabbits

Test system

Amount / concentration applied:

dosed with either 0.1 or 0.005 ml of n-butyl acetate directly onto the eye

Duration of treatment / exposure:

The eyelid was held together for one second

Observation period (in vivo):

The eyes were scored by the Draize method at one and four hours, and 1, 2, 3, and 7 days after dosing. At the Day 1 observation time point, fluorescein staining was used to detect corneal injury.

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Remarks on result:

other: see irritant/corrosive response data provide below

Irritant / corrosive response data:

Instillation of 0.1 ml of n-butyl acetate did not cause corneal injury in any of 6 eyes, although iritis (mean scores were 0.7 at 1 and 4 hours) was noted in the eyes of four animals and minor to moderate conjunctival irritation (mean scores were 1.3 , 1.7, and 2.7 for redness, chemosis, and discharge, respectively at 4 hours) developed in all 6 animals. All of these signs of irritation resolved within 48 hours of dosing. Instillation of 0.005 ml of n-butyl acetate did not cause corneal injury in any of 6 eyes, although mild iritis (mean score of 0.3 at 1 and 4 hours) was noted in the eyes of two animals and minor to moderate conjunctival irritation (mean scores of 1.5 , 0.7, and 1.5 for redness, chemosis, and discharge, respectively at 4 hours) developed in all 6 animals. These signs of irritation resolved within 24 hours in 2 of the six animals and within 48 hours in the remaining four animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

not irritating