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EC number: 211-199-0 | CAS number: 633-96-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- 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
- 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.
Reference
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
- 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.
Reference
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.