Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

Endpoint summary

Description of key information

Skin irritation/corrosion: non-irritating, similar to OECD 404, non-GLP, 0.5 g test substance, occlusive, rabbit, 1977, K2
Eye irritation: non-irritating, similar to OECD 405, non-GLP, 0.1 g test substance, rabbit, 1977, K2

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

details about test substance, animal source/breeder, in life dates and animal enviroment (air changes per hour) are missing

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

12 May 1981 / The study was performed before the guideline was published.

Deviations:

yes

Remarks:

exposure duration (24h instead of 6h), no washing step, no readings after 30-60 minutes and 48 hours, different scoring

Qualifier:

equivalent or similar to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act

Version / remarks:

Sect. 191.11 (February 1965)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: /
- Age at study initiation: 17-20 weeks
- Weight at study initiation: 3.09 kg male and 3.10 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, sterile
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 hours

Type of coverage:

occlusive

Preparation of test site:

other: shaved and right hand site abraded

Vehicle:

other: PEG 50 % aqueous solution

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml containing 0.5 g
- Concentration (if solution): 50 %

VEHICLE
- Amount(s) applied (volume or weight with unit): 1 ml
- Concentration (if solution): 50 %

10 g of the test compound mixed with 12 ml of a 50 % aqueous solution of polyethylene glycol to make a suspension of 20ml, 10 ml of which was applied to each test site on a 2.5 cm square gauze pad.

Duration of treatment / exposure:

24h

Observation period:

72h

Number of animals:

5 male, 1 female

Details on study design:

TEST SITE
- Area of exposure: back/flanks
- % coverage: 10
- Type of wrap if used: aluminium foil secured with "Sleek" adhesive tape

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: abraded skin

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: all time points

Score:

1.2

Max. score:

8

Remarks on result:

other: slightly irritating according Draize system

Irritant / corrosive response data:

24 hours:
Slight to well defined erythema was seen on all sites and very slight to slight oedema on 5/6 intact and 4/6 abraded.sites.
72 hours:
All sites were normal.

Generally, there was very little difference seen in the reactions between intact and abraded sites.

The primary irritation score was 1.2.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the test and the primary irritation score of 1.2, no indication for classification according to GHS is indicated.

Executive summary:

In the primary skin irritation test, similar to OECD 404, male and female New Zealand White rabbits were dermally treated with the test substance.

Five male and one female were singly housed and shaved (and partially abraded) before the substance was applied as a aqueous solution with polyethylene glycol as vehicle.

The test substance was covered by an occlusive coverage and the test site was treated for 24 hours.

After the removal of the coverage, the site was observed for further 72 hours.

There was very little difference seen in the reactions between intact and abraded sites and the primary irritation score was 1.2.

The test substance is not considered to be skin irritant to rabbits.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

details about test substance, animal source/breeder, in life dates and animal enviroment (air changes per hour) are missing

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

12 May 1981 / The study was performed before the guideline was published.

Deviations:

yes

Remarks:

period of treatment different to guideline, slightly different scoring system

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act

Version / remarks:

Sect.191.12 (February 1965)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: /
- Age at study initiation: 17-20 weeks
- Weight at study initiation: 3.09 kg male and 3.10 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, sterile
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 hours

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

1 s eye held closed, 30 s treatment with open eye

Observation period (in vivo):

1, 24, 48 and 72 h

Number of animals or in vitro replicates:

5 male, 1 female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water 200 ml
- Time after start of exposure: 30 sec

SCORING SYSTEM:
Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

The eye reactions were assessed as follows:

Score : Assessment
0 non irritant
>0 - 10 minimally irritant
11 - 25 slightly irritant
26 - 56 moderately irritant
57 - 84 markedly irritant
> 84 extremely irritant


TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h

Score:

10

Max. score:

80

Remarks on result:

other: washed and unwashed

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24h

Score:

5

Max. score:

80

Remarks on result:

other: 3 unwashed, 1 washed

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48h

Score:

5

Max. score:

80

Reversibility:

fully reversible within: 72h

Remarks on result:

other: unwashed only

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h

Score:

ca. 5

Max. score:

20

Remarks on result:

other: washed and unwashed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h

Score:

2

Max. score:

20

Remarks on result:

other: washed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h

Score:

5

Max. score:

20

Remarks on result:

other: unwashed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48h

Score:

2

Max. score:

20

Remarks on result:

other: washed and unwashed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

ca. 1

Max. score:

20

Reversibility:

fully reversible within: 6d

Remarks on result:

other: unwashed

Irritant / corrosive response data:

Conjunctiva.
A very slight to slight reaction was seen in all treated eyes one hour after the application of the compound. There was very little change by 24 hours. These had returned to normal as follows: 48 hours (one washed eye), 72 hours (one unwashed and 2 washed eyes) and 6 days (2 unwashed eyes).
Cornea.
Slight opacity with damage to the surface epithelium was seen in all treated eyes at one hour. This was still present in the 3 unwashed and one washed eye at 24 hours. These had returned to normal as follows: 48 hours (one washed eye), 72 hours (2 unwashed eyes) and 6 days (one unwashed eye).

Generally, washed eyes tended to show a slightly less severe reaction than unwashed eyes.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is a minimal eye irritant but based on the results, there is no indication for an irritating effect based on GHS.

Executive summary:

In the eye irritation test, similar to OECD 405, male and female New Zealand White rabbits were treated with the test substance as such.

Five male and one female were singly housed.

After the test substance was applied to one eye, the lid was closed for 1 second and left open for 30 seconds. Afterwards, the eye was washed with warm water and observed 1, 24, 48 and 72 hours after application. The right eye of each animal seved as control.

The slight reactions were reversible within 24 hours after application. Generally, washed eyes tended to show a slightly less severe reaction than unwashed eyes.

The test substance is not considered to be eye irritant to rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In the primary skin irritation test, similar to OECD 404, male and female New Zealand White rabbits were dermally treated with the test substance. Five male and one female were singly housed and shaved (and partially abraded) before the substance was applied as a aqueous solution with polyethylene glycol as vehicle. The test substance was covered by an occlusive coverage and the test site was treated for 24 hours. After the removal of the coverage, the site was observed for further 72 hours. There was very little difference seen in the reactions between intact and abraded sites and the primary irritation score was 1.2. The test substance is not considered to be skin irritant to rabbits.

 

Eye irritation

In the eye irritation test, similar to OECD 405, male and female New Zealand White rabbits were treated with the test substance as such. Five male and one female were singly housed. After the test substance was applied to one eye, the lid was closed for 1 second and left open for 30 seconds. Afterwards, the eye was washed with warm water and observed 1, 24, 48 and 72 hours after application. The right eye of each animal seved as control. The slight reactions were reversible within 24 hours after application. Generally, washed eyes tended to show a slightly less severe reaction than unwashed eyes. The test substance is not considered to be eye irritant to rabbits.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. In both studies evaluating the skin and eye irritating potential, no effects could be observed after application of the test substance. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fifteenth time in Regulation (EC) No. 2020/1182.