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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
year of publication: 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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:
- Name of test material (as cited in study report): n-Butyl acetate
- Analytical purity: 99%
- Product No.: B-396 (Source: Fisher)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single exposure (no washing indicated in report)
Observation period (in vivo):
up to 14 days
Number of animals or in vitro replicates:
4
Details on study design:
READING TIMES: 24, 48 and 72 h as well as 7 and if required 14 days after instillation of test material

SCORING SYSTEM: according to OECD TG 405 (Draize-Scores)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #3 each
Time point:
other: 24-28-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect observed
Irritation parameter:
cornea opacity score
Basis:
animal: #2 and #4 each
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effect observed
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #1, #2, #3, and #4 each
Time point:
other: 24-48-72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect observed
Irritation parameter:
chemosis score
Basis:
animal: #2, #3 and #4 each
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
Corena score was 0 at any time for animal #1 and #3. For animals #2 and #4 cornea score was 1 at the 24 h reading but effects vanished thereafter. There were no iridial effects in all animals. At the 24, 48 and 72 h reading all animals showed some conjunctival redness (score 1), but this effect persistet only in animal #2 until the 7 days reading. No conjunctival redness was observed in animal #2 at the 14 days reading. Chemosis score was 0 throughout the experiment for animal #1. Animals #2, #3, and #4 showed some swelling (score 1) at the 24 hour reading but did not show any effects at the 48 h reading. Slight discharge was seen in 3 out of 4 animals at the 24 h reading, but not thereafter.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study N-Butyl Acetate was not irritating to the eyes.
Executive summary:

New Zealand white rabbits were exposed to 0.1 mL of undiluted n-Butyl acetate and were observed for up to 14 days where necessary. Overall no iritis occurred and only barely perceptible effects were seen on the cornea (score:1) as well as the conjunctivae (redness score:1, chemosis score: 1), which were all reversible within a maximum of 14 days (ECETOC, 1998).

This study was judged to be reliable with restrictions (RL2) and therefore selected as key study.