Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

Developmental toxicity / teratogenicity

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2002

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

not specified

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

EC Number:

211-199-0

EC Name:

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

Cas Number:

633-96-5

Molecular formula:

C16H12N2O4S.Na

IUPAC Name:

sodium;4-[(2E)-2-(2-oxonaphthalen-1-ylidene)hydrazinyl]benzenesulfonate

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

88 mated females at the gae of pairing
Body weight: 169-244 g
Minimun age: 11 weeks

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous solution + 1% CMC

Duration of treatment / exposure:

From day 6 to day 17 post coitum (last treatment)

Frequency of treatment:

Once daily

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0
Basis:
nominal in water
Control group

Doses / concentrations 2

Remarks:

Doses / Concentrations:
5 mg/kg bw/day
Basis:
nominal in water

Doses / concentrations 3

Remarks:

Doses / Concentrations:
40 mg/kg bw/day
Basis:
nominal in water

Doses / concentrations 4

Remarks:

Doses / Concentrations:
320 mg/kg bw/day
Basis:
nominal in water

No. of animals per sex per dose:

22 females per group per dose

Control animals:

yes, concurrent no treatment

Details on study design:

The test material was homogenized in bi-distilled water containing 1% CMC. The mixture of the test article and vehicle were prepared daily before administration. According to the result of dose range finding studies the following concentrations were used for the study: 0, 5, 40, 320 mg/kg bw/day.
The animals (22 mated female rats, each concentration) were treated by oral gavage, once daily from day 6 through to day 17 post coitum (last treatment).
A standard dose volume of 10 ml/kg bw was used. Females were sacrificed on day 21 post coitum and the foetuses were removed after Caesarean section. The examination of the dams and foetuses was performed in accordance with international recommendations.

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

320 mg/kg bw/day (nominal)

Based on:

act. ingr.

Basis for effect level:

other: developmental toxicity

2

Dose descriptor:

NOAEL

Effect level:

5 mg/kg bw/day (nominal)

Based on:

act. ingr.

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

320 mg/kg bw/day (nominal)

Based on:

test mat.

Basis for effect level:

other: general signs

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Based on the result, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Orange 7 was considered to be 5 mg/kg bw/day for the maternal organism and 320 mg/kg bw/day for the foetal organism.

Executive summary:

Based on the result, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Orange 7 was considered to be 5 mg/kg bw/day for the maternal organism and 320 mg/kg bw/day for the foetal organism.