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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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

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

Test material

Constituent 1
Test material form:
liquid: viscous
Details on test material:
- Substance type: Technical product.
- Storage condition of test material: No data.

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: 2.20-2.84 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum period of five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19-21°C.
- Humidity: 58-65%
- Air changes: approximately 15 air-changes per hour.
- Photoperiod: 12 hours dark / 12 hours light.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml.
Duration of treatment / exposure:
One single treatment.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hours and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
One rabbit was initially treated. After consideration of the ocular responses, two additional animals were treated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No.

SCORING SYSTEM: according to numerical evaluation according to the Draize method.

TOOL USED TO ASSESS SCORE: standard ophtalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
No adverse corneal or iridial effects were noted during the study. Minimal conjunctival irritated was noted in all treated eyes at the one hour
observation. All treated eyes appeared normal 24 hours after treatment.

Any other information on results incl. tables

Table 1: Mean scores for eye irritation

Reaction

Reading (hours)

Individual scores

Male (2.84 kg)

Male (2.50 kg)

Male (2.20 kg)

Corneal opacity

1

0

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Iris

1

0

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Conjunctivae

1

2

6

6

24

0

0

0

48

0

0

0

72

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008/EC.
Conclusions:
Based on the results of a GLP-compliant guideline study, 2-amylanthraquinone is considered to be not irritating to rabbit eyes.
Executive summary:

Eye irritation/corrosion caused by 2-amylanthraquinone was studied in three rabbits. 0.1 ml of 2-amylanthraquinone was placed into the conjunctival sac of each of the rabbits and the effects were examined up to 72 hours. No adverse corneal or iridial effects were noted during the study. Minimal conjunctival irritated was noted in all treated eyes at the one hour observation. All treated eyes appeared normal 24 hours after treatment. The test substance is considered to be non irritant to the eye of the rabbit.