2,3-dihydro-1,4-dihydroxyanthraquinone

Endpoint summary

Description of key information

Dihydrochinizarin was not irritating in an in vivo skin irritation test

The test substance was not irritating in an eye irritation test

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-06-01 - 1982-06-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

not mentioned

GLP compliance:

no

Remarks:

Study conducted prior to implementation of OECD GLP

Species:

rabbit

Strain:

New Zealand White

Remarks:

HC:NZW

Details on test animals or test system and environmental conditions:

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

- 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

6 x 6 cm2 clipped at both flanks with hair cutting machine

Vehicle:

water

Remarks:

the solid test substance was pasted with water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of paste (mixture with water) dispensed on gauze patch (2.5 x2.5 cm2)


VEHICLE
- water

NEGATIVE CONTROL
6x6 cm2 clipped at other flank without treatment

Duration of treatment / exposure:

4h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm2 at the flank
- Type of wrap if used: gauze fixed with elastic tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48, 72 hours, 7 days

SCORING SYSTEM:
- Method of calculation: Draize (DRAIZE, J.H.,Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials the US, p.~6, 1959).

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

- Other adverse systemic effects: not described, no mortalities

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	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	0/0/0	0/0/0
24 h	0/1/1	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0.33/0.33	0/0/0
Reversibility*)	c.	c.
Average time (unit) for reversion	48 h

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

 

 

Interpretation of results:

GHS criteria not met

Conclusions:

Dihydrochinizarin was not irritating in the in vivo skin irritation test under the experimental conditions described in this report. Judgment is based on erythema and edema calculated as mean scores for each animal following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility. The following mean scores were calculated: erythema 0/0.33/0.33 and edema 0/0/0. Full reversibility of all scores was reached within 48 hours.

Executive summary:

In a primary dermal irritation study, performed in accordance with OECD guideline 404, three adult New Zealand White rabbits were dermally patch (2.5 x 2.5 cm2) exposed for 4 hours to 0.5 g of test substance moistened with water. Test sites were covered with semi-occlusive dressing. The contralateral flank served as control. Animals were then observed for 7 days.

Irritation was scored by the method of (DRAIZE, J.H., Appraisal of the safety of chemicals in foods,drugs and cosmetics, Association of Food and Drug Officials of the US, p.46, 1959). 60 minutes after patch removal, all scores were 0.0. At the 24 hours scoring, 2/3 animals showed very slight erythema (score 1). No edema was observed. Full reversibility of all scores was reached within 48 hours.

In this study, the test substance is not a dermal irritant according to the criteria of LCLP, EU GHS (Regulation (EC) No 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

Study conducted prior to implementation of OECD GLP

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

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

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

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

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

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)

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation

Based on available and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.

Eye irritation

Based on available and relevant data, the test substance does not need to be classified for skin irritation according to regulation (EC) 1272/2008.