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EC number: 201-963-1 | CAS number: 90-04-0
- 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
Description of key information
A NOAEL of 16 mg/ kg bw x d and a LOAEL of 80 mg/ kg bw x d were derived for systemic toxicity in a 28-days toxicity study with oral application. Major effects were toxicity of the hematological system.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 16 mg/kg bw/day
Additional information
In a 28-day oral study according to OECD guideline 407 conducted in male and female Wistar rats (5 animals per sex per dose; dailyapplication of 0, 16, 80 or 400 mg o-anisidine/kg bw via gavage), no substance-related (i.e.unspecific) effects were observed at a dose level of 16 mg/(kg bw x d). In animals dosed with 80 mg/kg bw, yellow urine and a slight haemolytic anemia were noted. These effects were more pronounced at400 mg/kg bw. Bilirubin levels in blood and relative liver weights of female animals wereincreased. In both sexes, there were morphological changes of thespleen (haemosiderosis, hyperaemia, and increased extramedullary haematopoiesis) as well as increased erythrocyte formation in the bone marrow (nevertheless no methemoglobin formation was observed) evident within the histopathological examinations made. The high dose group (400 mg/kg)showed salivation, squatting and inflated abdomen at day 15. Reduced body weights andan increase in relative liver and kidney weights was seen in male animals, while in females the glutamic pyruvictransaminase (GPT) levels were increased.Increase of drinking waterconsumption, bilirubin and urea-nitrogen levels in blood, as well as increased relativespleen weights were obviuos in animals of both sexes. From this study, a NO(A)EL of 16 mg/(kg bw x d) and a LOAELof 80 mg/(kg bw x d) was derived.
In another study F344 rats and B6C3F1 mice were subjected to an oral range finding study for o-anisidine hydrochloride (CAS no. 123 -29 -2). The conditions used were as follows: application of 0 - 1,000 - 3,000 -10,000 or 30,000 ppm o-anisidine hydrochloride for 7 weeks via diet to 5 animals/sex/dose (applied doses corresponding to the following body doses in rats: ca. 75, 225, 750 or 2,250 mg/kg bw and day; and in mice: ca. 150, 450, 1,500 or 4,500 mg/kg bw and day).
The results are summarized in the RAR in such a way: doses, which are greater or equal "10,000 ppm in rats resulted in dose-dependent weight depression of more than 10% and moderately enlarged spleens, which were black and granular; spleens of male rats administered 1,000 or 3,000 ppm were granular. In mice doses of (> or equal) 3,000 ppm resulted in dose-dependent weight depression of more than 10%; at doses of (> or equal)10,000 ppm the spleens were also black and enlarged (NCI, 1978)."
Furthermore, the effects seen in the main 2 year-study performed by the NCI (1978) are described too. F344 rats fed with doses of 0, 5000 or 10000 ppm of o-anisidine hydrochloride were killed at 103 -107 weeks and for all animals (the ones found dead as well as the ones sacrificed in the end) histopathological examinations were performed. There was a dose-related depression of body weight noted, but all the non-neoplastic lesions found in histopathology were considered to be not compound related.
In mice the applied doses were 0, 2500 or 5000 ppm and the surviving animals were killed at weeks 104 or 105 of the bioassay. Effects observed are the same as for rats (see above).
There are no studies available concerning repeated inhalation or dermal exposure in experimental animals.
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: hematopoiesis; cardiovascular / hematological: spleen
Justification for classification or non-classification
On the basis of the observed haematotoxicity including changes of haematological parameters and morphological effects in corresponding organs (hemosiderin deposition in spleen), at a dose level of 400 mg/kg bw and less pronounced at a dose level of 80 mg/kg bw a classification as STOT re category 2 might be appropriate. But in view of the existing classification which guaranties a high protection level an additional classification as STOT re category 2 seems dispensable.
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