Registration Dossier
Registration Dossier
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EC number: 269-054-2 | CAS number: 68186-92-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77896.
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to OECD 422 (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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- 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.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- females & males
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- females & males
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- females & males
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- females & males
- 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)
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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.
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