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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study completion date: 08 April 1974
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:
1974
Report date:
1974

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
EC Number:
282-316-0
EC Name:
Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
Cas Number:
84145-95-9
Molecular formula:
C32H17CrN6O11S.2Na
IUPAC Name:
disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)
Test material form:
solid: particulate/powder
Details on test material:
Identity FAT 20013/D TE
Batch 1502011 (China)
Purity determined in this study
Appearance black powder at 20°C
Smell neutral
pH-Value pH-value of a solution of 2% (w/w) = 9.2
Expiration date August 03rd, 2020
Storage to be stored at room-temperature
Specific details on test material used for the study:
Name: FAT 20013/A
Purity: 59%

Test animals

Species:
rat
Strain:
other: CFY strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
Weight: 99 to 118g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
FAT 20013/A was prepared as a 30% suspension in water and administered at a maximum dosage volume of 16.7ml/kg bodyweight. Rats treated with water alone (16.7ml/kg) served as controls.
Doses:
0 and 5000 mg/kg
No. of animals per sex per dose:
5 animals per sex
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 95% CL not specified
Mortality:
No mortality observed.
Clinical signs:
Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhoea and diuresis. The urine of all. animals was observed to be blue-black in colour. A slight increase in respiratory rate was observed six hours after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of compound FAT 20013/A in rats is greater than 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 20013/A was evaluated in a limit test using rats according to method similar to OECD test guideline 401.

5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, animals were killed by exsanguination under ether anesthesia and an autopsy performed.

No deaths occurred. Signs of reaction to treatment, observed within a few hours of dosing included piloerection, lethargy, moderate diarrhea and diuresis. The urine of all animals was observed to be blue-black in colour. At autopsy, no changes caused by the administration of FAT 20013/A were seen.

In conclusion, the acute oral LD50 of FAT 20013/A in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

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