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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data from secondary source

Data source

Reference
Reference Type:
other: Secondary source
Title:
Acute oral toxicity study of test chemical
Author:
NTP (National Toxicological Program)
Year:
2000
Bibliographic source:
NTP (National Toxicological Program) by Agency for Toxic Substances and Disease Registry, 2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Evaluation of acute oral toxicity of test chemical in rats.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material: 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
-Common Name: D & C Red no. 27
- Molecular formula: C20H4Br4Cl4O5
- Molecular weight : 785.6746 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Administration / exposure

Route of administration:
other: Oral- by stomach tube
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
4600, 6800, 10200, 15400 and 23100 mg/kg (4.6, 6.8, 10.2, 15.4 and 23.1 g/kg)
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: No data available
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed at 4600mg/kg bw, while Rats treated with 15400 and 23100 mg/kg all died within 96 hr.
Two rats from each of these groups died after 36 hr.
Clinical signs:
Sedation and anorexic were observed within one hr of treatment with doses of 6800 and 10200 mg/kg.
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The LD50 value was considered to be > 4600mg/kg bw when rats were treated with test chemical orally.
Executive summary:

In acute oral toxicity study, test chemical was administered by stomach tube to groups of 4 Sprague Dawley rats in doses of 4600, 6800, 10200, 15400 and 23100 mg/kg. The rats were then observed for 14 days. No effects were seen at the lowest dose, sedation and anorexic were observed within one hour of treatment with doses of 6800 and 10200 mg/kg. Two rats from each of these groups died, the remaining appeared normal after 36 hr. Rats treated with15400 and 23100 mg/kg all died within 96 hr. The test chemical was excreted percutaneously and in urine and feces. Hence,LD50 value was considered to be > 4600mg/kg bw when rats were treated with test chemical orally. Therefore according to CLP regulation, the test chemical cannot be classified for Acute oral toxicity.