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

Endpoint summary

Description of key information

Studies of Pigment Red 57 -Sr and of other members of the same category indicate that Pigment Red 57 -Sr 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:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Physical state: powwder, red
- Analytical purity: the test substance has not been fully characterized analytically.
- Lot/batch No.: CS-485
- Stability under test conditions: has not been determined analytically.
- Storage condition of test material: room temperature
- Name of test material (as cited in study report): LITHOL RUBIN D 4569-SR-LACK, Substance number 91/3

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR . K . THOMAE GMBH, 7950 BIBERACH, BRD
- Age at study initiation: YOUNG ADULT ANIMALS
- Mean weight at study initiation: 150 - 300 g +- 20%
- Fasting period before study: AT LEAST 16 HOURS, WATER WAS AVAILABLE AD LIBITUM .
- Housing: SINGLE HOUSING.
- Diet (e.g. ad libitum): KLIBA-LABORDIAET 343, KLINGENTALMUEHLE AG 4303 KAISERAUGST, SWITZERLAND , AD LIBITUM .
- Water (e.g. ad libitum): TAP WATER AD LIBITUM PER DAY
- Acclimation period: AT LEAST 1 WEEK


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 H/12 H

Route of administration:

oral: gavage

Vehicle:

other: aqueous tylose solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 22 g/100 mL, 0 .5% solution of Tylose CB 30.000 in Aqua Bidest.
- Justification for choice of vehicle: Aqueous formulation corresnponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2200 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Frequency of observations for signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once ach workday for the individual animals.
- Frequency of general observations and mortality: check was made twice each workday and once on mortality: Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.
- Frequency of weighing: individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: Yes, necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before euthanisation with CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 200 mg/kg bw

Mortality:

No mortality observed

Clinical signs:

other: No abnormalities observed

Gross pathology:

No pathologic findings noted

Other findings:

Skin coloured red, discoloured feces (red) at day 1, noted in all animals

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 200 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

Key result

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:

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

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

other: read-across

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Additional information

Acute oral toxicity

Pigment Red 57-Sr caused no toxicity in rats in two GLP and OECD guideline compliant studies at a limit dose of 2200 and 2000 mg/kg bw (Miyata 2005 and BASF 1992, respectively).

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 57(Sr) by the presence Ca2 + instead of Sr2 +. In addition, a valid study is available for Pigment Red 48:1 which contains Ba2+ instead of Sr2+ and contains a chloride on the sulfonated amine moiety. 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.

Acute dermal toxicity

The hazard of acute dermal toxicity is derived from experimental data on analogue pigments (48:1, 48:2, 48:3, and 57:1) present in the category. For these pigments, the LD50s all exceeded 2500 mg/kg bw. As a result, it can be concluded that Pigment Red 57-Sr is also not acutely toxic via the dermal route.

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.