2-[[6-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]naphthalene-1,5-disulphonic acid, sodium salt

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[[6-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]naphthalene-1,5-disulphonic acid, sodium salt

EC Number:

280-744-2

EC Name:

2-[[6-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]naphthalene-1,5-disulphonic acid, sodium salt

Cas Number:

83763-57-9

Molecular formula:

C24H11ClF2N5Na3O10S3 C24H14ClF2N5O10S3.xNa C24H13ClF2N5NaO10S3 [724.014 gr/mol]

IUPAC Name:

sodium 6-(2-{6-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-1-hydroxy-3-sulfonaphthalen-2-yl}diazen-1-yl)-5-sulfonaphthalene-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Orange 64

Test animals

Species:

rat

Strain:

Wistar

Remarks:

+ 10 male Syrian hamsters

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany (rats); Hoechst AG, Frankfurt, Germany (hamsters)
- Weight at study initiation: ca. 200 g (rats); ca. 100 g (hamsters)
- Housing: Makrolon Type III cages, 5 animals/cage
- Diet (e.g. ad libitum): Altromin-R-ssniff ad lib.
- Water (e.g. ad libitum): ad lib.

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Remarks:

according to IMIV RLE, G., A. EBEN, Arch. Toxikol. 30, 115, 1973

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

22.4 µm

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: KIMMERLE, G., A. EBEN, Arch. Toxikol. 30, 115, 1973
- 785 hPa pressure, impulse very 2 seconds, impulse = 0.5 seconds

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

1960 mg/m³ air

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Statistics:

N/A

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LC50

Remarks:

rat

Effect level:

> 1 960 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Remarks:

hamster

Effect level:

> 1 960 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality in rats or hamsters

Clinical signs:

other: No symptoms in rats or hamsters

Body weight:

No effects in rats or hamsters

Gross pathology:

Gross pathology: no findings
Histopathology: rats more sensitive, slight signs of irritation and inflammation of lung tissue; hamsters: no significant findings

Other findings:

Rats: orange discolouration of lungs, trachea, feces, nephrons and testes
Hamsters: orange discolouration of lungs, trachea, nephrons, feces, urine and testes

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LC50 (inhalation) in male rats and hamsters was found to be >1960 mg/m³ air. The substance is not classifiable according to CLP criteria.