p,p',p''-tris(diethylamino)trityl alcohol

Acute Toxicity: oral

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:

other: Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Acute (Mouse and Rat) and Short-term (Rat) Toxicity Studies on Blue VRS

Author:

D. E. Hall and I. F. Gaunt

Year:

1967

Bibliographic source:

Fd Cosmet. Toxicol Vol. 5, pp. 165-170

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

The acute toxic effect of Blue VRS was evaluated in rats by a single oral dosage

GLP compliance:

not specified

Test type:

other: No data

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt

EC Number:

204-934-1

EC Name:

Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt

Cas Number:

129-17-9

Molecular formula:

C27H32N2O6S2.Na

IUPAC Name:

sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)cyclohexa-2,5-dien-1-ylidene]methyl}benzene-1,3-disulfonate

Details on test material:

- Name of test material (as cited in study report): Blue VRS
- Molecular formula (if other than submission substance): C27H31N2O6S2.Na
- Molecular weight (if other than submission substance): 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

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Carworth Farm E

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
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: Clinical sign were observed

Statistics:

The LDs0 values with 95% confidence limits calculated according to Litchfield & Wilcoxon (1949).

Results and discussion

Preliminary study:

No data avaiable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No effect on survival and clinical sign

Mortality:

No effect on survival of treated male and female rats were observed.

Clinical signs:

other: No effect on clinical sign of treated male and female rats were observed.

Gross pathology:

No data avaiable

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:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 was considered to be > 10000 mg/kg bw when in SPF Carworth Farm E male and female rats were treated with Blue VRS orally by gavage.

Executive summary:

In a acute oral toxicity study, SPF Carworth Farm E male and female rats were treated with Blue VRS orally by gavage. No effect on survival and clinical sign were observed in treated rats. Distinct blue coloration of the skin showed that some of the colouring had been absorbed although substantial amounts were excreted in the faeces. Therefore, LD50 was considered to be > 10000 mg/kg bw when SPF Carworth Farm E male and female rats were treated with Blue VRS orally by gavage.