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EC number: 270-185-2 | CAS number: 68412-38-4 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77899.
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- (Peer review was conducted by a Japanese toxicological expert group at March 5, 2001; However only secondary source material available)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- Mar 1996
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Antimony nickel titanium oxide yellow
- EC Number:
- 232-353-3
- EC Name:
- Antimony nickel titanium oxide yellow
- Cas Number:
- 8007-18-9
- Molecular formula:
- (Ti, Sb, Ni) O2
- IUPAC Name:
- Antimony nickel titanium rutile
- Details on test material:
- Purity: 100%
Lot/batch no: 4879
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj; CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 4 d
- Proof of pregnancy: vaginal plug or sperm in vaginal smear - Duration of treatment / exposure:
- Exposure period: male: 46 days from 14 days prior to mating; female: 41-45 days from 14 days prior to mating to day 4 postpartum throughout mating and pregnancy
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: male: 47 days; female: 42-46 days - Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 1, 2, 3, 5, 7, 10 and 14 d; then weekly
BODY WEIGHT: Yes
- Time schedule for examinations: 1, 2, 3, 5, 7, 10 and 14 d; then weekly
- Oestrous cyclicity (parental animals):
- Estrous cycle was determined before mating
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, viability index, body weight and necroscopy
- Postmortem examinations (parental animals):
- GROSS NECROPSY
ORGAN WEIGHTS - Reproductive indices:
- Estrous cycle, copulation index (number of pairs with successful copulation/number of pairs mated X 100), fertility index (number of pregnant animals/number of pairs with successful copulation X 100), gestation index (number of females with live pups/number of living pregnant females X 100), gestation length, nursing index, number of pregnant females, corpora lutea and implantation sites, implantation index (number of implantation sites/number of corpora lutea X 100), delivery index (number of pups born/number of implantation sites X 100),
- Offspring viability indices:
- number of live pups on day 4/number of live pups on day 0 X 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 500 and 1000 mg/kg bw/day: yellow or yellowish brown feces in all of 12 male and female rats of each group
The scab-formation in the back in the 250 mg/kg group and the trauma and scab-formation in the lower eyelid in the 500 mg/kg group were observed each in one female, but they were not considered to be affected by treatment - Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 250 and 1000 mg/kg bw/day: a significant shortening of the activated partial thromboplastin time (APTT) was observed in males
250 mg/kg bw/day: In females, significant high values of mean corpuscular hemoglobin (MCH) and platelet were observed, but they were changes that cannot be seen in the dose groups of 500 mg/kg or more. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A significant low value of potassium (K) was observed in the 1000 mg/kg group males, but it was considered to have no toxicological significance.
In females, significant low value of cholinesterase (ChE) in the 250 mg/kg group, significant low value of sodium (Na) in the 500 mg/kg group, and significant low value of GPT in the 1000 mg/kg group were observed, but, since there were no changes found in the related items, they were considered to have no relevance to the administration - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 250 mg/kg bw/day: In males, a significant increase was observed in urine specific gravity, but it was a change that cannot be seen in the dose groups of 500 mg/kg or more.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: myocardial degeneration of heart in three males, eosinophilic bodies of the proximal tubule epithelium in one male, atrophy of the seminiferous tubules of testes in three males, intraluminal cell debris of the epididymis in one male, and lymphocyte infiltration of the prostate in four males were observed.
As for all the above changes, no significant difference was observed in the frequency of appearance, as compared to the control group.
In females, in the 1000 mg/kg group, erosion of the tongue was observed in one animal, and mineralization in the cortico-medullary junction of the kidney was observed in three females. In addition, the atresia of vagina and the inflammation of the uterine horn were observed in one animal in which the atresia of vagina was seen at necropsy (infertility example), and the atresia of vagina was a congenital anomaly and it was considered as the cause of infertility.
As for all the above changes, no significant difference was observed in the frequency of appearance, as compared to the control group. - Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- effects observed, non-treatment-related
- Description (incidence and severity):
- As for the incidence of females with normal estrus interval, copulation index, fertility index, gestation index, length of gestation, and nursing index on lactation day 4, there was no significant difference observed in each dose group. Unsuccessful copulation was observed in the 250 and 500 mg/kg groups, each in one pair. In the estrous cycle inspection of females of these pairs, continuous diestrus was observed, but from the fact that it was not observed in the 1000 mg/kg group, it was not considered as the effect due to treatment. One non-pregnant female was observed in the 1000 mg/kg group. As for this female, the atresia of vagina that is a congenital anomaly was observed in the pathological examination and it was considered to be the cause of infertility.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- As for the live pups, there was nothing except for the trauma in the abdominal region observed in one female in the 500 mg/kg group.
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Except for the scab observed in one male of the 1000 mg/kg group, there was no abnormality observed in any of the dead pups. As for the pups necropsied on day 4 of lactation, yellowish white portion of the liver was observed in one male of 250 mg/kg group and in one male of 1000 mg/kg group, and trauma found in the observation of general condition was observed in one female of 500 mg/kg group, but there was no other abnormality observed.
- Histopathological findings:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the effects of the test substance's administration on the male and female reproduction and on the newborns were not observed in each dose group. Therefore, the no-observed-effect level (NOEL) of the test substanc's administration with repeated dose in this test conditions for the reproduction of parent animals and the no-observed-effect level (NOEL) for the development of newborns were considered to be 1000 mg/kg/day or more.
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