C.I. Solvent Blue 43

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08/09/2012

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Principles of method if other than guideline:

The acute oral toxicity study of Solvent blue-43 was conducted in wistar albino rats. The study was conducted under the OECD Guideline-423 for testing of chemicals following Good Laboratory Practice. The healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization to standard laboratory condition for period of one week.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

disodium 4-{[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium 3-{[ethyl({4-[(4-{ethyl[(3-sulfonatophenyl)methyl]amino}cyclohexa-2,5-dien-1-ylidene)(2-sulfonatophenyl)methyl]phenyl})amino]methyl}benzene-1-sulfonate

Cas Number:

61813-75-0

Molecular formula:

C61H70N6S3O9

IUPAC Name:

disodium 4-{[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium 3-{[ethyl({4-[(4-{ethyl[(3-sulfonatophenyl)methyl]amino}cyclohexa-2,5-dien-1-ylidene)(2-sulfonatophenyl)methyl]phenyl})amino]methyl}benzene-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report) : Solvent Blue 43
- Molecular formula (if other than submission substance): C61H70N6S3O9
- Molecular weight (if other than submission substance): 1136
- Substance type : solid
- Physical state : powder
- Analytical purity : 99.55

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

unchanged (no vehicle)

Doses:

The test was administered by oral route by using of oral cannula at the dose volume of 10 ml/kg b.wt.

No. of animals per sex per dose:

3

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Starting dose 300 mg/kg body weight:

Step- I:

The test compound was dissolved in distilled water and administered orally at the dose level of 300 mg/kg body weight (dose volume 10ml/kg) to three female rats. Whereas, vehicle control group treated with the distilled water at the dose level of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication during first four hours of test compound administration. Thereafter, all the animals were observed periodically at one hour interval for 24 hrs and once daily for a period of 14 days. The necropsy was performed on all animals which died during the study or were sacrificed at termination of the study.

The test compound administered at the dose level of 300 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation. No clinical signs were observed in vehicle control group.

The necropsy finding did not show any gross pathological changes in animal which was sacrifice during the end of experimentation.

 

 

Step -II:

After 72 hrs, the result of step-I was confirmed by administration of same dose level (300 mg/kg. b.wt) of test compound in additional three animals of same sex (OECD-423 guidelines).

The test compound administered at the dose level of 300 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation. No clinical signs were observed in vehicle control group.

The necropsy finding did not show any gross pathological changes in animal which was sacrificed during the end of experimentation.

Final dose 2000 mg/kg body weight:

Step-I

The test compound was dissolved in distilled water and administered orally at the dose level of 2000 mg/kg body wt. (dose volume 10 ml/kg) to three female rats. All the animals were closely observed for clinical sign of toxicity and mortality gross pathological changes individually once in 30 minutes, 1, 2, 4 and 6 hrs intervals during the first 24 hrs and thereafter, once daily for a period of 14 days. The necropsy was performed on all animals which died during the study or were sacrificed at termination of the study.

The necropsy was performed on all animals which died during the study or were sacrificed at termination of the study.

The test compound administered at the dose level of 2000 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation.

The necropsy finding did not show any gross pathological changes in animal which was sacrifice during the end of experimentation.

Step -II:

After 72 hrs, the result of step-I was confirmed by administration of same dose level (2000 mg/kg. b.wt) of test compound in additional three animals of same sex (OECD-423 guidelines).

The test compound administered at the dose level of 2000 mg/kg b.wt did not produce any mortality throughout the period of observation 14 days. Furthermore, test compound solvent blue-43 did not elicit any clinical signs of intoxication throughout the period of observation. No clinical signs were observed in vehicle control group.

The necropsy finding did not show any gross pathological

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It is concluded that the test compound Solvent blue-43 sponsored by Unique Chemicals & Allied Products following the guideline OECD-423 is acutely nontoxic to wistar albino rats.

Executive summary:

Finally, it is concluded that the test compound Solvent blue-43 following the guideline OECD-423 is acutely nontoxic to wistar albino rats. According toGlobally Harmonized Classification System for Chemical Substances, it comes under the Globally Harmonized Classification (GHC) Category-5and LD₅₀cutoff is 5000 mg/kg b.wt.