Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Special study of reproductive toxicology
Author:
WHO Food additives
Year:
1981
Bibliographic source:
WHO Food additives Series 16- 1981 , submitted to WHO by EEC Colours Group

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
developmental study perfored on SPF-derived Wistar rats when treated with Brilliant Black PN
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Brilliant Black PN (2519-30-4)- Molecular formula (if other than submission substance):Not applicable- Molecular weight (if other than submission substance):Not applicable- Substance type:Organic- Physical state:Solid

Test animals

Species:
rat
Strain:
Wistar
Details on test animals and environmental conditions:
SexMale/FemaleExposureFrom day 0-19 of pregnancy

Administration / exposure

Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data available
Details on mating procedure:
No data available
Duration of treatment / exposure:
For first and second study : from day 0-19 of pregnancy
Frequency of treatment:
Exact frequency was not menton
Duration of test:
Till F1 generation
No. of animals per sex per dose:
First study:15 animalsSecond study: 30 animals
Details on study design:
No data available

Examinations

Maternal examinations:
The number of corpora lutea in each ovary was recorded
Ovaries and uterine content:
The number of corpora lutea in each ovary was recorded and the foetuses examined.
Fetal examinations:
Live foetuses, embryonic and foetal resorptions and dead foetuses were counted and the number and position of implantation sites were recorded.
Statistics:
No data available
Indices:
No data available
Historical control data:
No data available

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effectsDetails on maternal toxic effects:At autopsy, no signs of embryo-toxicity or teratogenicity were observed

Effect levels (maternal animals)

Dose descriptor:
NOEL
Effect level:
2 500 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Remarks on result:
other: behaviour of the dam, embryo-toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:No abnormalities in condition or behaviour of the dams were observed in either study

Effect levels (fetuses)

Remarks on result:
not measured/tested

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The end point for the developmental study was found to be NOEL at 2500 mg/kg bw for SPF-derived Wistar rats when treated with Brilliant Black PN (2519-30-4).
Executive summary:

Developmental study were performed onSPF-derived Wistar female rats. Study were conducted in two stages as the preliminary study four groups of 15 pregnant rats Brilliant Black PN was administered by gavagefrom day 0-19 of pregnancy.

In second study, 30 pregnant rats were used with same protocol.

On 21 days the animals were killed and ovaries and uterus removed.The number of corpora lutea in each ovary was recorded and the foetuses examined. Live foetuses, embryonic and foetal resorptions and dead foetuses were counted and the number and position of implantation sites were recorded.

 In the second study, half the foetuses in the control and top dose groups were examined for skeletal malformations and half for visceral defects. No abnormalities in condition or behaviour of the dams were observed in either study. At autopsy, no signs of embryo-toxicity or teratogenicity were observed.

The end point for the developmental study was found to be NOEL at 2500 mg/kg bw for SPF-derived Wistar rats when treated with Brilliant Black PN (2519-30-4).