Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Endpoint summary

Description of key information

The test item was tested negative for acute skin and eye irritating properties according to OECD 404 and OECD 405.

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:

Nov/Dec 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

without GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1980

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd, Huntingdon, UK
- Age at study initiation: no data
- Weight at study initiation: 2.8 to 3.1 kg
- Housing: single
- Diet (e.g. ad libitum): ssniff K ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours; 7 and 14 days

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: full
- Type of wrap if used: covered with an elastic adhesive bandage

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

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

Due to the staining of the test material detection of reddening was temporarily difficult; at 1 h no erythema value was derived in all animals, at 24 h in one animal. However, as the other two animals did not show any reddening, this was assumed to also be true for the third animal

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritation

Other effects:

reversible staining of the skin

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal irritation/corrosion study according to OECD 404 the test item is considered to be non-irritating to the skin.

Executive summary:

A sample of the test item was tested in three female New Zealand White rabbits for acute dermal irritating properties according to OECD guideline 404. The dermal exposure period was 4 hours under semi-occlusive conditions. The test item did not cause any skin effects. Thus, under the conditions of this study, the test item can be considered as non-irritating.

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:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

no GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Age at study initiation: adult rabbits were used
- Weight at study initiation: 3 to 3.2 kg
- Housing: individually in stainless steel cages
- Diet: "Ssniff K" (Ssniff Spezialdiäten GmbH, Soest), ad libg
- Water: tap water was available for ad libitum consultion
- Acclimation period: at least 14 days

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

IN-LIFE DATES: December 1983

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL pulverized test substance (max 0.1 g)

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0.2

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

24 hours after treatment, no adverse effects were seen in the treated eyes

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute eye irritation/corrosion study according to OECD 405, the test substance did not cause any eye-irritating effects.

Executive summary:

In a primary eye irritation study, 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three female New Zealand White rabbits for 24 hours, and subsequently washed out with physiological saline. The animals were observed for a period of 7 days. Irritation was scored by the method by Draize. Besed on the results of this study, the test item is not irritating to the eye.

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

The test item was tested negative for acute skin and eye irritating properties according to OECD 404 and OECD 405. After a dermal exposure period of 4 hours no skin effects were observed in rabbits within an observation period of 7 days. Accordingly, an exposure period of 24 hours to the eye did not cause any irritating effects in rabbit eyes. Based on these results, the test substance is considered to be not irritating to skin or to the eye.