Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate

Endpoint summary

Description of key information

Pigment Red 48:2(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:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The exposure duration was 24 hours. No 48-hour observation point included.

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1955).

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24h occlusive application and short post-observation period. No recording of body weight development and clinical signs.

GLP compliance:

no

Specific details on test material used for the study:

- Appearance: red powder
- Batch No.: EG 9146

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Healthy New Zealand White rabbits (Porton strain) aged 10 - 13 weeks with average body weights of 2.84 Kgs {males) and 2.58 Kgs (females), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the trial.

The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (± 1°) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Type of coverage:

occlusive

Preparation of test site:

other: both shaved and abraded

Vehicle:

other: 50% polyethylene glycol in water

Controls:

not required

Amount / concentration applied:

10 g of the test compound was mixed with 20 mL of deionized water to form a suspension, of which 1.5 mL was applied to the test sites on 2.5 cm square gauze pads (dose of 0.5 g per application site).

Duration of treatment / exposure:

24h

Observation period:

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours.

Number of animals:

3 males and 3 females

Details on study design:

Twenty-four hours prior to dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two sites lateral to the midline of the back were used on each rabbit. Immediately before the application of the compound, the right hand side was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand side remained intact.

10g of the compound mixed with 10ml of a 50% aqueous solution of polyethylene glycol to make a suspension of 20ml, 1.0ml of which was applied to each test site on a 2.5cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours and f or any further period considered necessary up to 14 days.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h and 72h

Score:

0

Max. score:

4

Remarks on result:

other: values for intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: values for intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: values for abraded skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: values for abraded skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

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:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

No assessment of non-ocular local and systemic adverse effects, no rationale for in vivo testing

GLP compliance:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report):PD 1201
- Batch EG 9146
- Substance type: red pigment
- Physical state: solid
- Purity test date: not available
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Composition: 95% C.I. Pigment Red 48 - Calcium Salt and 5% modified wood rosin derivative

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 10 - 13 weeks
- 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 08:00 - 18:00 hours

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g per eye

Duration of treatment / exposure:

single application. For half of the treated eyes, the eyes were rinsed with 200 mL of water 30 seconds after application.

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

The rabbits were examined at 1,6, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "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. Corneal damage was assessed after staining with flourescein.

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:

other: 1h and 24h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: Grade 1 redness of the conjunctivae observed in all animals at the 1h reading.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

other: Grade 2 chemosis observed in animals with unrinsed eyes at the 1h reading.

Other effects:

Rinsing of the eyes had a minor beneficiary effect.

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 48:2(Ca) is not irritating to skin as determined in four studies with rabbits performed between 1972 and 1978. The study performed in 1977 by W. Bradley was chosen as key study for skin irritation because the composition and origin of the sample is documented in the report and the study procedure and results are described in sufficient details. The procedure is more stringent than theone described in the OECD testing guideline 404 (1981) as it involves 24h occlusive application onto intact and abraded skin. Under these conditions, no erythema and mild transient edema was observed.

Pigment Red 48:2(Ca) is not irritating to eyes as determined in four studies with rabbits performed between 1972 and 1978. The study performed in 1977 by W. Bradley was chosen as key study for eye irritation because the composition and origin of the sample is documented in the report and the study procedure and results are described in sufficient details. The studies were performed prior to the introduction of GLP, but their design is comparable to OECD testing guideline 405. As for skin irritation, the overall study results range between “slightly irritating” to “non irritating” due to the influence of the additives.

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.