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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:
bad general condition, sedation, nausea, increased diuresis
Body weight:
no influence on body weight gain
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.