Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Endpoint summary

Description of key information

Pigment Red 57:1(Ca) is not irritating to skin and eye.

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:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Clinical signs and body weights not reported.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Body weights and clinical signs were not reported.

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Irgalite Rubine 6BL G861831
- Substance type: pigment
- Physical state: solid
- Purity test date: not indicated
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured in August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- described as red powder
- Analytical purity: 89% Pigment Red 57:1]

Species:

rabbit

Strain:

Californian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: (Hylyne Commercial Rabbits Ltd
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.71 kg (males) and 2.5 kg (females)
- Housing: single caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10h light daily


IN-LIFE DATES: From: July 21, 1987 To: July 24, 1987

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: 50% aqueous solutionof polyethylene glycol

Controls:

not required

Amount / concentration applied:

500 mg per animal

Duration of treatment / exposure:

4h

Observation period:

72 hours. As no findings were observed, the experiment was discontinued.

Number of animals:

2 males and 2 females

Details on study design:

Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. One test site close to the mid-line of the back was used on each rabbit.
2.5 g of the test compound was mixed with 4 ml of a 50% aqueous solutionof polyethylene glycol to give a suspension of 5 ml, 1.0 ml of which was applied to the test site on a 6 cm square gauze pad. This was covered with aluminium foil secured with "Transpore" surgical tape. The test site was then covered by a 6" wide 'Coban' self adhesive bandage in order to retain the test substance in close contact with the skin. After 4 hours the dressing was removed and the compound residue rinsed from the application site using lukewainn water. Sites were assessed for oedema and erythema 30 - 60 minutes after removal of the occlusive dressing. Further assessments were made at 24, 48 and 72 hours.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

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:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): TK 10868 / Irgalite Rubine 6BL
- Analytical purity: 89% Pigment Red 57:1
- Substance type: red pigment
- Physical state: solid
- Purity test date: not available
- Lot/batch No.: G861831
- Expiration date of the lot/batch: open, manufactured August 1986
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Species:

rabbit

Strain:

Californian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.44 kg (males) and 2.31 kg (males)
- Housing: single caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum) :ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours daily from 0800 - 1800 hours


IN-LIFE DATES: From: July 20, 1987 To: July 24, 1987

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.06 g per eye, corresponding to 0.1 mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

2 males and 2 females

Details on study design:

The rabbits were examined, using a direct ophthalmoscope, at 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Pigment Red 57:1(Ca) is not irritating to skin as determined in many studies with rabbits performed between 1972 and 2006. The study performed in 1987 by K. O’Brian was chosen as key study for skin irritation because it was performed with a commercial sample according to the OECD testing guideline 404 (1981) and GLP and contains detailed sample information such as composition, origin and storage conditions in the study report. The overall study results range between “slightly irritating” to “non irritating”. These differences are due to sample composition and differences in testing protocols or vehicles. Commercial products of Pigment Red 57:1 differ in their content of additives that are added depending on the intended application. Typical additives are resin, surfactants, inorganic fillers and dye-stuff. Irritating properties can be affected by the content of additives which explains the high number of irritation studies for this substance. Most of the older studies follow a more stringent testing protocol issued in 1959 by the US Association of Food and Drug Officials (“Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics”). This protocol requires 24h occlusive application to both abraded and intact skin and skin lesions do not need to be scored until full healing. None of the available studies gave an indication that Pigment Red 57:1 has irritating properties on skin.

The key study for eye irritation (O’Brian 1987) was performed with a commercial product following OECD testing guideline 405 (1987) and the principles of GLP. The commercial product had an adequately high pigment content and caused slight conjunctival redness in all animals at 1 hour and in one male and one female 24 hours after compound application. Minimal chemosis and a compound stained slight ocular discharge were seen in one male and one female 1 hour after application of the test article. All eyes were normal within 48 hours after application of the test article. The findings are attributed to the additives rather than the pigment itself and are typical for most studies.The variation in additive content is also reflected in the amount the test material needed to obtain an application volume of 0.1 ml: Applied amounts range from 0.3 mg (indicating a high pigment content, as the relative density of the pigment is 1.7) to 0.1 mg. The available data show that Pigment Red 57:1 and the majority of the commercial products are not irritating to eyes.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.