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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
EC Number:
278-113-1
EC Name:
Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
Cas Number:
75199-08-5
Molecular formula:
C27H19CrN10O11S.2Na C27H19CrN10Na2O11S
IUPAC Name:
Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: male: ca. 9 weeks; female: ca. 14 weeks
- Weight at study initiation: male/female mean = 179 g
- Housing: Makrolon Type III cages with dedusted wood granulate
- Diet (e.g. ad libitum): Altromin R 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.5°C
- Humidity (%): 55 - 65%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 30 mL
- Justification for choice of vehicle: water soluble substance

MAXIMUM DOSE VOLUME APPLIED: 7300 mg/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 1000 mg/kg bw considered to cause no effects
Doses:
1000, 3100, 4000, 5000, 6300, 7300 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice/day, once/day (weekends)
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
Probit analysis

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 004 mg/kg bw
Based on:
test mat.
95% CL:
4 270 - 5 680
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 552 mg/kg bw
Based on:
act. ingr.
Mortality:
occured from 3100 - 7300 mg/kg bw
Clinical signs:
bad general condition, diarrhea, sedation, nausea, increased diuresis, prone and lateral position (after 1 min of gavage)
Other findings:
No symptoms occured at 1000 mg/kg bw
No differences between female and male animals

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on a calculated LD50 of 5004 mg/kg bw, experimentally derived in Wistar rats (oral, gavage), the test item is not considered to be acutely toxic via oral exposure. The test item is not classifiable according to the CLP Regulation since the LD50 is >2000 mg/kg.