N-butyl acetate

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

other: Draize

Principles of method if other than guideline:

Three male and three female New Zealand White rabbits with 0.5 ml of n-butyl acetate applied to the clipped, intact skin under a gauze patch and loosely covered with impervious sheeting. The animals were restrained for the 4-hour exposure period. Excess liquid was removed at the end of the exposure period. Skin reactions were scored by the Draize method at one hour and 1, 2, 3, 7, 10 and 14 days post-exposure.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

clipped

Amount / concentration applied:

0,5 ml

Observation period:

Skin reactions were scored by the Draize method at one hour and 1, 2, 3, 7, 10 and 14 days post-exposure.

Number of animals:

Three male and three female

Irritation parameter:

other: Mean Draize

Basis:

mean

Score:

0

Reversibility:

fully reversible

The four hour exposure did not cause erythema, edema, or any other signs of skin irritation. Mean Draize scores for erythema , eschar, and edema were 0.0 for all animals tested at all post-exposure intervals.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

not irritating

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three male and three female New Zealand White rabbits

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

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.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

not irritating

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
best data available

Justification for selection of eye irritation endpoint:
best data available