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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
three-generation reproductive toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
No data
GLP compliance:
not specified
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
not specified
Remarks:
Doses / Concentrations:
0
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
5 mg/kg
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
50 mg/kg
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
150 mg/kg
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
500 mg/kg
Basis:
nominal in diet
No. of animals per sex per dose:
10 males and 20 females
Control animals:
yes, concurrent no treatment
Parental animals: Observations and examinations:
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Oestrous cyclicity (parental animals):
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Sperm parameters (parental animals):
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Litter observations:
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Postmortem examinations (parental animals):
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Postmortem examinations (offspring):
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Other effects:
no effects observed
Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
Remarks on result:
not determinable due to absence of adverse toxic effects
Reproductive effects observed:
not specified
Conclusions:
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg. The tested substance does not cause any adverse effect and it could be concluded that teh susbtance does not show any toxicity for reproduction.
Executive summary:

No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg. The tested substance does not cause any adverse effect and it could be concluded that teh susbtance does not show any toxicity for reproduction. The NOAEL value is 500 mg/kg.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Justification for selection of Effect on fertility via oral route:

The submitted studies perfomed both on Acid Orange 7 and on similar substance 1 completely assess the endpoint.

Effects on developmental toxicity

Description of key information

Based on the results obtained from OECD 414, no concern can be arised by Acid Orange 7.

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
not specified
GLP compliance:
yes
Limit test:
no
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
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
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.
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
Dose descriptor:
NOAEL
Effect level:
320 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: general signs
Abnormalities:
not specified
Developmental effects observed:
not specified
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.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
320 mg/kg bw/day
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Based on the results obtained from the follwing tests perfomed on Acid Orange 7 and on similar substance 1, no concern can be arised by Acid Orange 7.

Justification for classification or non-classification

No classification for toxicity to reproduction is warranted under Regulation 1272/2008.

Additional information