Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-09-06 to 1999-09-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Feb. 1987
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Jan. 1997
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl hexanoate
EC Number:
204-640-3
EC Name:
Ethyl hexanoate
Cas Number:
123-66-0
Molecular formula:
C8H16O2
IUPAC Name:
ethyl hexanoate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: albino New Zealand White (SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißlegg
- Weight at study initiation: 1.8 - 2.0 kg b.w.
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 mL 0.9% sodium chloride after Fluorescein was instilled
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Cornea
Opacity degree of density (Area most dense was taken for reading): Scores 0 to 4, where 0 – No ulceration or opacity, and 4 – Complete corneal opacity, iris not discernable.
Area of cornea involved: Scores 1 to 4, where 1 – One quarter or less but not zero, and 4 – More than 3 quarters up to whole area.
Iris
Iris: Scores 0 to 2, where 0 – Normal, and 2 – No reaction to light, hemorrhage, gross destruction (any or all of these).
Conjunctiva
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris): Scores 0 to 3, where 0 - Vessels normal, and 3 - Diffuse beef red.
Chemosis: Scores 0 to 4, where 0 - No swelling, and 4 - Swelling with lids more than half closed.
Discharge: Scores 0 to 3, where 0 - No discharge, and 3 - Discharge with moistening of the lids and hairs, and considerable area around the eye.

TOOL USED TO ASSESS SCORE: visual examination; with UV-light after instilling fluorescein and rinsing

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0.33
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0.33
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean of observations after 24, 48, 72 hours
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study reports mean scores for cornea opacity, iris lesion, redness of conjunctiva and oedema of conjunctiva (chemosis) as 0.0, 0.0, 0.2 and 0.0. Therefore from these results, the test substance is non-irritating to the eye.
Executive summary:

The eye irritant effect of the test substance was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye lrritation/Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997. Four female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing. Slight signs of irritation were observed on the treated eyes. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated as 0.0, 0.0, 0.2 and 0.0 for cornea opacity, iris lesion, redness of conjunctiva and oedema of conjunctiva, respectively. According to the Regulation (EC) No 1272/2008 of 16 December 2008, the test substance does not meet CLP classification for eye irritation.