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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Refer chapter 13 for the detailed analogue justification.

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:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
EC Number:
274-417-3
EC Name:
Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
Cas Number:
70210-20-7
Molecular formula:
C26H20ClN7O10S3.3Na
IUPAC Name:
trisodium 5-({4-chloro-6-[methyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
FAT 40034/B

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: In-house breeding
- Age at study initiation: 5 weeks
- Weight at study initiation: 118 g
- Fasting period before study: 18 h
- Housing: caged singly
- Diet: commercial pelleted diet (Oakes Special Diet with added Vit. E) ad libitum):
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The compound (as a 50 % w/v suspension in water) was administered as a single dose by gavage to rats which had been fasted for 18 h, at a rate of 10 ml/kg equivalent to 5 g/kg of compound.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
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, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Results and discussion

Preliminary study:
None
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 deaths occurred.
Clinical signs:
No clinical symptoms were recorded.
Body weight:
None
Gross pathology:
At autopsy no changes caused by the administration of FAT 40034/A were seen.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of FAT 40034/A in SD rats is greater than 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 40034 was evaluated in a limit test using Sprague-Dawley rats according to a methodology similar to OECD 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, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No clinical symptoms were recorded and no deaths occurred. At autopsy no changes caused by the administration of FAT 40034/A were seen. In conclusion, the acute oral median lethal dose (LD50) of FAT 40034/A in SD rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.