Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.