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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:
from 1990-10-03 to 1991-01-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylanthraquinone
EC Number:
201-535-4
EC Name:
2-ethylanthraquinone
Cas Number:
84-51-5
Molecular formula:
C16H12O2
IUPAC Name:
2-ethyl-9,10-anthraquinone
Details on test material:
- Name of test material (as cited in study report): 2-ETHYLANTHRAQUINONE
- Physical state: pale yellow flakes
- Analytical purity: >95%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: 146 - 332
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.64 - 3.12 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.)
- Water (e.g. ad libitum): ad libitum (mains drinking water)
- Acclimation period: 5 days in minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21
- Humidity (%): 52 - 65
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1990-10-03 To: 1990-10-10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of the rabbits remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL corresponding to approximately 70 mg
Duration of treatment / exposure:
one single application
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. An additional observation was made in one animal on day 7 to assess the reversibility of the ocular effects.
Number of animals or in vitro replicates:
1 male, 2 females (1 initially treated, 2 treated after consideration of the ocular responses produced in the first treated animal)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM:

Initial local pain reaction:
No response: 0
A few blinks only, normal within one or two minutes: 1
Rabbit blinks and tries to open eye, but reflex closes it: 2
Rabbit holds eye shut and puts pressure on lids, may rub eye with paw: 3
Rabbit holds eye shut vigorously, may squeal: 4
Rabbit holds eye shut vigorously, may squeal, claw at eye, jump and try to escape: 5

The Draize scale was used for numerical scoring of the ocular irritation. Using the numerical data obtained, a modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem., 1962 13 281-289 was used to classify the ocular irritancy potential of the test material.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.78
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Individual and mean scores for cornea, iris and conjunctivae

Rabbit Number and Sex (Bodyweigh in kg)

Time after treatment

Corneal Opacity

Iridial Inflammation

Conjunctival Redness

Conjunctival Chemosis

125 Male (2.64)

24 hours

1

1

2

2

48 hours

1

0

1

1

72 hours

0

0

1

0

Total

2

1

4

3

Mean

0.7

0.3

1.3

1.0

92 Female (3.12)

24 hours

0

0

1

1

48 hours

0

0

1

0

72 hours

0

0

0

0

Total

0

0

2

1

Mean

0.0

0.0

0.7

0.3

100 Female (3.01)

24 hours

0

0

1

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Total

0

0

1

0

Mean

0.0

0.0

0.3

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material 2-ethylanthraquinone was classified as a mild irritant to the rabbit eye according to a modified Kay and Calandra classification system. The test material is classified as non-irritant to the rabbit eye according to Regulation (EC) No 1272/2008 (CLP).
Executive summary:

A study was performed to assess the irritancy potential of the test material 2-ethylanthraquinone to the eye o f the New Zealand White rabbit. The method used followed that described in the OECD TG 405.

A single application o f the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Diffuse corneal opacity and iridial inflammation was confined to one treated eye. All treated eyes appeared normal 72 hours after treatment or on day 7.

The test material was classified as a mild irritant to the rabbit eye according to a modified Kay and Calandra classification system. The test material is classified as non-irritant to the rabbit eye according to Regulation (EC) No 1272/2008 (CLP).

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