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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Toxicity Studies on test chemical
Author:
Hall et al.
Year:
1967
Bibliographic source:
Fd Cosmet. Toxicol

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
The acute toxic effect of test chemucal was evaluated in rats by a single oral dosage
GLP compliance:
not specified
Test type:
other: No data
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material :Blue VRS- Molecular formula :C27H31N2O6S2.Na- Molecular weight :566.672g/mole- Substance type:Organic- Physical state:Solid- Purity: 94.5%- Impurities (identity and concentrations):0.2% subsidiary dyes

Test animals

Species:
rat
Strain:
other: SPF Carworth Farm E
Sex:
male/female
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
10000 mg/Kg bw
No. of animals per sex per dose:
5 male, 5 female
Control animals:
not specified
Details on study design:
Details on study design- Duration of observation period following administration: 7 days- Other examinations performed: Clinical sign were observed
Statistics:
The LD50 values with 95% confidence limits calculated according to Litchfield & Wilcoxon (1949).

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No effect on survival of treated male and female rats were observed.
Clinical signs:
No effect on clinical sign of treated male and female rats were observed.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
Distinct blue coloration of the skin showed that some of the colouring had been absorbed although substantial amounts were excreted in the faeces.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute oral toxicity dose (LD50) was considered to be >10000 mg/kg bw, when 5 male and 5 female SPF Carworth Farm E rats were treated with test chemical via oral gavage route.
Executive summary:

Acute oral toxicity study was conducted by using test chemical in 5 male and 5 female SPF Carworth Farm E rats at the dose concentration of 10000 mg/Kg bw via oral gavage route. Animals were observed for mortality and clinical sign for 7 days. The LD50 values with 95% confidence limits calculated according to Litchfield & Wilcoxon (1949). No effect on survival of treated male and female rats were observed. No effect on clinical sign of treated male and female rats were observed. Distinct blue coloration of the skin showed that some of the colouring had been absorbed although substantial amounts were excreted in the faeces. Hence, LD50 value was considered to be >10000 mg/kg bw, when 5 male and 5 female SPF Carworth Farm E rats were treated with test chemical via oral gavage route.