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

Endpoint summary

Description of key information

Studies of Pigment Red 48:2 and of other members of the same category indicate that Pigment Red 48:2 is not acutely toxic via the oral, inhalation, and dermal route of exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Body weights not recorded.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

- 95% C. I. Pigment Red 48 - Calcium Salt
- 5% modified wood rosin derivative
- A red powder labelled PD 1201 EG 9146

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats were caged singly and kept in a room maintained at a temperature of 21°C (+2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Animals: Healthy Sprague-Dawley derived rats, bred on the premises, aged 6 - 7 weeks, having an average body weight of 176 g (males)
and 142 g ( females )

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

50% aqueous solution

Details on oral exposure:

Rats had been fasted for 18 h prior to dosing at a rate of 20 mL/kg.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Mortality:

none

Clinical signs:

other: no adverse findings

Gross pathology:

no adverse findings

Other findings:

In all animals the faeces were stained red for approximately 48 hours.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

Please see the category read-across justification in the category object.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 518 mg/m³ air

Based on:

other: read-across

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4.76 mg/L air

Based on:

other: read-across

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

1 518 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

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 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

BASF test

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): C.I. Pigment Red 48:2 / Litholscharlach 4440
- Substance type: Mono azo dye
- Physical state: solid
- Other: Ca-salt with "Harzseife" (resinate)

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder, SPF, Wiga
- Mean weight at study initiation: males: 134 g; females: 118 g

ENVIRONMENTAL CONDITIONS: not reported

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal, p.c., 50 cm2

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g
- Concentration (if solution): 50 % aqueous suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No weighing was performed. Observation was several times at the day of exposure and presumably daily exception of weekends and holidays afterwards.
- Necropsy of survivors performed: yes

Statistics:

LD 50 was estimated approximately

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

No mortality was observed

Clinical signs:

other: No abnormalities detected

Gross pathology:

No abnormalities detected

Other findings:

Red substance residues, redness not detectable.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Additional information

Commercial products of Pigment Red 48:2 differ in their content of additives that are added depending on the intended application. Typical additives are resin, surfactants, inorganic fillers and dye-stuff. The content or identity of the additives is not documented in all studies as these were performed prior to the introduction of GLP. As no adverse effects were noted and very high doses tested, the influence of additives on acute toxicity is considered to be negligible.

Acute oral toxicity

The key study for acute oral toxicity (Drake 1977) was performed in rats with sample of adequately high pigment content. The procedure is comparable to OECD test guideline 423 (2001) with the exception that the body weight was not recorded at the end of the observation period. All rats survived a single application of 5000 mg/kg bw test substance by gavage without showing clinical signs of toxicity. No adverse findings were noted upon necropsy.  Rats excreted red feces during the first two days which is caused by the staining properties of the red pigment. The key study is representative for all available study reports on acute oral toxicity.  

Data on the sulfonated amine moiety of Pigment Red 48:1 is also available (4-amino-6-chlorotoluene-3-sulphonic acid; CAS 88-51-7). This moiety is not acutely toxic via the oral route (LD50 >7500 mg/kg bw).

Acute inhalation toxicity

The hazard of acute inhalation toxicity is derived from experimental data on analogue pigments present in the category. A valid study is available for Pigment Red 57:1 which differs from Pigment Red 48:2 by the absence of a chlorine on the sulfonated amine moiety. In addition, a valid study is available for Pigment Red 48:1 which contains Ba2+ instead of Ca2+. Acute inhalation exposure to aerosol of Pigment Red 48:1 at a concentration of 4.76 mg/L caused mortality in one of ten rats (Capelle 1993) as assessed in a GLP compliant study following OECD testing guideline 403. The study with Pigment Red 57:1 (Sachsse 1976) was performed in rats with a commercial product following a protocol which is comparable to OECD testing guideline 403 (1981). A limit test was performed with the highest concentration of dust that was technically achievable (1518 ± 176 mg/m3 air). No mortality, no clinical signs and no findings upon necropsy were observed. Overall, Pigment Red 48:2 is considered to be of low acute toxicity.  

Data on the sulfonated amine moiety of Pigment Red 48:1 is also available (4-amino-6-chlorotoluene-3-sulphonic acid; CAS 88-51-7).This moiety is not acutely toxic via the inhalation route (LC50 >13.0 mg/L).

Acute dermal toxicity

The key study for acute dermal toxicity (BASF 1974) was performed in rats with a commercial product following a protocol which is comparable to OECD testing guideline 402 (1987). It was performed prior to the introduction of GLP but is documented adequately. The commercial product contained an unknown amount of resin which is acceptable as a dose of 2500 mg/kg bw was applied. No indication of adverse findings was observed.  

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 acute oral, dermal or inhalation toxicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.