Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex

Endpoint summary

Description of key information

Studies of Pigment Red 48:3 and of other members of the same category indicate that Pigment Red 48:4 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

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 401 (Acute Oral Toxicity)

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): Litholechtscharlach 4290, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100 %
- Physical state: solid

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner (Breeder)
- Mean weight at study initiation: males 212 g, females 174 g

ENVIRONMENTAL CONDITIONS: not reported

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

10% aqueous suspension

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: Due to technical reasons a higher concentration than 10% could not be applicated.

Doses:

1000 mg/kg bw and 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: 7 days
- Frequency of observations and weighing: Weighing was only performed at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes

Statistics:

No statistics were performed because it is not necessary.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Mortality:

No mortality observed.

Clinical signs:

other: Red feces.

Gross pathology:

No abnormalities observed

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 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

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): Litholechtscharlach 4290, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100 %
- Physical state: solid

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga, Ottobrunn, D.
- Mean weight at study initiation: males 132 g, females 137 g

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/kg animal
- Concentration (if solution): 50 % aequous suspension
- For solids, paste formed: yes

Duration of exposure:

24 h

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 done. Observation was several times at the day of exposure and presumably daily exception of weekends and holidays afterwards.
- Necropsy of survivors performed: yes

Statistics:

LD50 was estimated approximately

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

0/10 animals died after the 24h h exposure

Clinical signs:

other: no abnormalities detected

Gross pathology:

No abnormalities detected

Other findings:

- After 24 hours: 10/10 red substance residues, local erythema not detectable.
- After 8 days: 10/10 animals: pink-coloured substance residues, no abnormality detected.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Additional information

Commercial products of Pigment Red 48:4 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

Pigment Red 48:4 caused no mortality upon singe gavage application to doses of 2500 mg/kg bw (BASF 1974), 6400 mg/kg bw (BASF 1973) or 10000 mg/kg bw (Ciba 1972), The procedures are comparable to OECD testing guideline 423 (2001) with the exception that the observation period was only seven or eight days. There were no clinical signs of toxicity. No adverse findings were noted upon necropsy.  

Data on the sulfonated amine moiety of Pigment Red 48:4 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 Two inhalation studies with poorly defined dust were performed with commercial products of Pigment Red 48:4 (BASF 1973 and 1974). For both studies, the test atmosphere was generated by an air flow of 200 l/min which passed through a column of 5 cm of the pigment (4.6 mg/m3 and 2.77 mg/m3). By visual inspection, the atmosphere was slightly dusty and by weight difference of the test item in the column, the concentrations were ca. 2.7 or 4.6 mg/L. A particle size distribution was not provided. However, as the pigment is a dusty material and only the smaller fraction would go into the air stream, the particle size should be in the low micrometeter range. Arrival of the test item in the chamber was verified by the red staining of the fur of the exposed animals. The exposure chamber was designed for whole body exposure. Both female and male rats were exposed for 8 hours and then observed for 7 days prior to necropsy. Body weight and clinical signs were monitored. All animals survived until the end of the observation period without clinical signs. There were no findings upon necrospsy. Additional information on acute inhalation toxicity is available from two similar pigments. A valid study is available for Pigment Red 57:1 which differs from Pigment Red 48:4 by the abesence of a chlorine on the sulfonated amine moiety and Ca2+ instead of Mn2 +. In addition, a valid study is available for Pigment Red 48:1 which contains Ba2+ instead of Mn2+. 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.

Data on the sulfonated amine moiety of Pigment Red 48:4 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

Two studies for acute dermal toxicity (BASF 1973 and 1974) were performed in rats with commercial products 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. 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.