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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

Constituent 1
Chemical structure
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 levelsopen allclose all
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
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.