Reaction mass of 2-(1,1-dimethylpropyl)anthraquinone and 2-(1,2-dimethylpropyl)anthraquinone

Eye irritation

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

Test material information

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animals #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

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.