Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-6-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-7-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

other: read across from analogue substance

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Scientific Opinion on the re-evaluation of Brillant Black BN (E151) as food additive

Author:

EFSA panel of Food Additives and Nutrient Sources added to Food (ANS)

Year:

2010

Bibliographic source:

EFSA

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Principles of method if other than guideline:

Pregnant SPF derived Wistar rats distributed in groups of 30 animals were gavage-fed at dose levels of 0, 250, 500 or 2500 mg/kg bw /day from day 0-19 of pregnancy.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

EC Number:

219-746-5

EC Name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

Cas Number:

2519-30-4

Molecular formula:

C28H21N5O14S4.4Na

IUPAC Name:

Food Black 1

Test animals

Species:

rat

Strain:

Wistar

Administration / exposure

Route of administration:

oral: gavage

Details on exposure:

daily

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

0-19 of pregnancy

Frequency of treatment:

daily

Duration of test:

21 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0,250, 500 and 2500 mg/kg bw /day
Basis:
actual ingested

No. of animals per sex per dose:

30 pregnant females per each dose

Control animals:

yes, concurrent no treatment

Examinations

Maternal examinations:

No abnormalities in condition or behaviour of the dams were observed.

Ovaries and uterine content:

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

Fetal examinations:

Half the foetuses in the control and top dose groups were examined for skeletal malformations and the other half for visceral defects. At autopsy, no signs of embryotoxicity or teratogenicity were observed.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

> 2 500 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

behaviour (functional findings)

clinical signs

dead fetuses

early or late resorptions

mortality

pre and post implantation loss

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

> 2 500 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

skeletal malformations

visceral malformations

Overall developmental toxicity

Developmental effects observed:

no

Lowest effective dose / conc.:

2 500 mg/kg bw/day (actual dose received)

Applicant's summary and conclusion

Conclusions:

The analogue substance was tested following a study desgin equivalent to OECD 414. Under the experimental conditions the NOALE is equal to 2500 mg/kg bw /day.

Executive summary:

Pregnant SPF-derived Wistar rats distributed in groups of 30 animals were gavage-fed with analogue substance 4 at dose levels of 0, 250, 500 or 2500 mg/kg bw/day from day 0-19 of pregnancy (TNO, 1979). No abnormalities in condition or behaviour of the dams were observed. On day 21, the animals were killed and ovaries and uterus removed. The number of corpora lutea and the number and position of implantation sites were recorded. Live foetuses, embryonic and foetal resorptions, and dead foetuses were counted . Half the foetuses in the control and top dose groups were examined for skeletal malformations and the other half for visceral defects. At autopsy, no signs of embryotoxicity or teratogenicity were observed. In a preliminary study with 15 rats per group, similar results were obtained