Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Basic Blue 99
Author:
American College of Toxicology
Year:
2007
Bibliographic source:
International Journal of Toxicology, 26(Suppl. 2):51–63, 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Developmental toxicity study have been carried out on rats to evaluate the effects of basic blue 99.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Basic blue 99- Molecular formula (if other than submission substance):C19-H20-Br-N4-O2.Cl- Molecular weight (if other than submission substance):451.75- Substance type:Organic- Physical state:Solid- Impurities (identity and concentrations):Purity-63%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
StrainPregnant Sprague-DawleyCD SexFemale

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on mating procedure:
- M/F ratio per cage:No data- Length of cohabitation:No data- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancyNo data- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.No data- Further matings after two unsuccessful attempts: [no / yes (explain)] No data- After successful mating each pregnant female was caged (how): No data
Duration of treatment / exposure:
Day 6th and 15th of gestation
Frequency of treatment:
once
Duration of test:
50mg/kg/days
No. of animals per sex per dose:
29
Control animals:
yes
Details on study design:
No data

Examinations

Maternal examinations:
Implantation sites ,resorptions
Ovaries and uterine content:
Yes
Fetal examinations:
The number of implantation sites, resorptions, living fetuses, and the number of corpora lutea were counted in each dam. The weight of the placenta, uterus, fetuses, dams, body weight gain, and sex of thefetuses were recorded. One-third of the litter was examined for soft tissue anomalies and the remaining fetuses were examined for skeletal anomalies.
Statistics:
No data
Indices:
No data
Historical control data:
No data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Remarks on result:
not measured/tested

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:No teratogenic effects observed.The No oberved effect level was considered to be 50mg/kg as there

Effect levels (fetuses)

Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Remarks on result:
other: developmental toxicity No effects

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The No oberved effect level was considered to be 50mg/kg as there
Executive summary:

Developmental toxicity study have been carried out totest the effects of basic blue 99 on rats at the dose of 50mg/kg/day at 6th and 15th day of gestation .

No dams died or showed cumulative toxicity effect from the applied dose of 50 mg/kg Basic Blue 99. Test animals had no differences in mean body weight gain in the course of gestation as compared to controls. There were no treatment related effects. Basic Blue 99 at 50 mg/kg did not cause embryotoxic or teratogenic effects under the test conditions.

Therefore the No oberved effect level was considered to be 50mg/kg.