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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
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-), [1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphthalenolato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-1-naphthalenesulfonato(3-)]-, lithium sodium
EC Number:
287-343-1
EC Name:
Chromate(2-), [1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphthalenolato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-1-naphthalenesulfonato(3-)]-, lithium sodium
Cas Number:
85480-62-2
Molecular formula:
C36H20ClCrLiN4NaO7S
IUPAC Name:
Chromate(2-), [1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphthalenolato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-1-naphthalenesulfonato(3-)]-, lithium sodium
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 = 174 - 185 g; female = 165 - 180 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/kg bw
- Justification for choice of vehicle: water soluble substance

MAXIMUM DOSE VOLUME APPLIED: 30 mL/kg bw
Doses:
1000, 2500, 3100, 4000, 5000 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, body weight
Statistics:
Probit analysis

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
occured from 4000 mg/kg bw
Clinical signs:
other: bad general condition, sedation, nausea, increased diuresis
Other findings:
No symptoms occured up to 3100 mg/kg bw
No differences between female and male animals
Symptoms occured 1 min after application and were gone after day 5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 male/female in Wistar rats (oral, gavage) is >5000 mg/kg. The test item is not classifiable according to the CLP Regulation since the LD50 is >2000 mg/kg.