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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Non GLP, no details on test material other than batch and substance code. As pigments are very stable substances and the composition for this substance code is available elsewhere, this is considered acceptable. Some experimental details not described in the report. Overall sufficient details and adequate study design.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Posttreatment observation did not include body weight. No information on frequency of cage-side observations.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

226-109-5

EC Name:

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

Cas Number:

5281-04-9

Molecular formula:

C18H14N2O6S.Ca

IUPAC Name:

calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate

Test material form:

solid: nanoform

Details on test material:

- Name of test material (as cited in study report): TK 10338
- Substance type: pigment
- Physical state: solid
- Analytical purity: no data in report, TK 10338 refers to a commercial product with 91% Pigment Red 57:1 and 9% additives.
- Lot/batch No.: EN 42374.76
- Expiration date of the lot/batch: no data
- Storage condition of test material: not indicated

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Specific details on test material used for the study:

- Name of test material (as cited in study report): TK 10338
- Substance type: pigment
- Physical state: solid
- Analytical purity: no data in report, TK 10338 refers to a commercial product with 91% Pigment Red 57:1 and 9% additives.
- Lot/batch No.: EN 42374.76
- Expiration date of the lot/batch: no data
- Storage condition of test material: not indicated

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Limited, bred on the premises
- Age at study initiation: no data
- Weight at study initiation: 180 to 185 g
- Fasting period before study: none
- Housing: in groups of 9 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days for inhalation tubes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 55%
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 14 light cycle


IN-LIFE DATES: not given

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Remarks:

snout and nostrils

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The dust was generated by injecting the test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Exposure chamber volume: not applicable, as nose-only exposure
- Method of holding animals in test chamber: Rats were kept on separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the dust.
- Source and rate of air: 17.5 L/min
- Method of conditioning air: not indicated
- System of generating particulates/aerosols: The dust was generated by injecting the test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Method of particle size determination: The concentration and the particle size distribution of the dust in the vicinity of the animals was monitored at 1 hour intervals throughout the dust exposure. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2micrometer (Schleicher and Schuell) at an air flow rate of 17.5 L/min.
- Treatment of exhaust air: not indicated
- Temperature, humidity, pressure in air chamber: not indicated


TEST ATMOSPHERE
- Brief description of analytical method used: The concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 micrometer (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min.
- Samples taken from breathing zone: indicated as "in the vicinity of the animals"


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 15% > 7 micrometer, 68% 3 - 7 micrometer, 8% 1 - 3 micrometer and 9% < 1 micrometer
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not calculated


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

1518 + 176 mg/m3 air

No. of animals per sex per dose:

9 males and 9 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 1 518 mg/m³ air (analytical)

Exp. duration:

4 h

Remarks on result:

other: ± 176 mg/m3 air

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 518 mg/m³ air (analytical)

Exp. duration:

4 h

Remarks on result:

other: ± 176 mg/m3 air

Mortality:

No mortality observed

Clinical signs:

other: No effects observed

Body weight:

Not determined

Gross pathology:

No adverse findings

Other findings:

None recorded

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification