2,3-dihydro-1,4-dihydroxyanthraquinone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01-06-1982 - 30-07-1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

Study conducted prior to implementation of OECD GLP

Test material

Test material information

Constituent 1

Reference substance name:

2,3-dihydro-1,4-dihydroxyanthraquinone

EC Number:

254-942-4

EC Name:

2,3-dihydro-1,4-dihydroxyanthraquinone

Cas Number:

40498-13-3

Molecular formula:

C14H10O4

IUPAC Name:

2,3-dihydro-9,10-dihydroxyanthracene-1,4-dione

Details on test material:

CAS # 40498-13-3

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

HC:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HACKING & CHURCHILL, Huntingdon, England
- Weight at study initiation: 3-4 kg
male

- Housing: individual cages
- Diet (e.g. ad libitum): ad libitum standard diet "Ssniff K 4", Versuchstierdiäten GmbH, Soest/Westfalen
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml (max. 0.1g) of finely pulverised test material

VEHICLE
no

Duration of treatment / exposure:

single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
24 h following application (if necessary) with physiological saline

SCORING SYSTEM:
DRAIZE, J.H., The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 49-52. Association of Food and Drug Officials of the United States, Topeka, Kansas, 1965

Tool used to assess score: fluorescin

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Animals #1 and #3 showed slight conjunctival redness 24 hours following test substance application.

Other effects:

- Other observations: discarge was observed until 24 hours following application (animals not individually identified)

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/0/1	0/0/0
24 h	0/0/0	0/0/0	1/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0	0.33/0/0	0/0/0
Area effected
Reversibility*)			c.
Average time (unit) for reversion			48 h

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was not irritating in the eye irritation test under the experimental conditions described in this report.

Executive summary:

In a primary eye irritation study, 0.1 ml (max. 0.1g) of the finely pulverised test substance (without vehicle) was instilled into the conjunctival sac of three adult New Zealand White rabbits. Animals then were observed for 7 days. Irritation was scored by the method of

DRAIZE, J.H. (The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 49-52. Association of Food and Drug Officials of the United States, Topeka, Kansas, 1965)

For two out of three animals, only slight to minimal conjunctival redness was observed until day 1. All effects were completely reversible within 48 h.

 

In this study, Dihydrochinizarin is not an eye irritant according to GHS.