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Toxicological information

Developmental toxicity / teratogenicity

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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

Constituent 1
Chemical structure
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-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

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 / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0
Basis:
nominal in water
Control group
Remarks:
Doses / Concentrations:
5 mg/kg bw/day
Basis:
nominal in water
Remarks:
Doses / Concentrations:
40 mg/kg bw/day
Basis:
nominal in water
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)

open allclose all
Dose descriptor:
NOAEL
Effect level:
320 mg/kg bw/day (nominal)
Based on:
act. ingr.
Basis for effect level:
other: developmental toxicity
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.