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EC number: 269-047-4 | CAS number: 68186-85-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77377.
- 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
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Peer reviewed authority database (Peer review was conducted by a Japanese toxicological expert group at March 5, 2001. However, detailed information were not available). Furthermore test results were taken for the OECD SIDS Intital assessment report for C.I. Pigment Yellow 53.
Data source
Referenceopen allclose all
- Reference Type:
- other: Peer reviewed databse
- Title:
- Unnamed
- Year:
- 2 002
- Reference Type:
- other: OECD Substance initial assessment report (SIAR)
- 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)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- C.I. Pigment yellow 53
- IUPAC Name:
- C.I. Pigment yellow 53
- 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 - Analytical verification of doses or concentrations:
- not specified
- 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 - Frequency of treatment:
- Once daily
- Details on study schedule:
- 42 to 47 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500, 1000 mg/kg bw/day (males & females)
Basis:
- 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.
- Sperm parameters (parental animals):
- Not examined.
- 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
- Postmortem examinations (parental animals):
- GROSS NECROPSY
ORGAN WEIGHTS - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed at 4 days of age.
- These animals were subjected to postmortem examinations (macroscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - 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:
- viability index (number of live pups on day 4/number of live pups on day 0 X 100), live birth index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
No clinical signs or mortality was observed during the study period.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
The test substance did not have any effect on body weight or food consumption.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No effects were observed on reproductive performances in males and females given any of the doses.
ORGAN WEIGHTS (PARENTAL ANIMALS)
Normal organ weights were observed.
GROSS PATHOLOGY (PARENTAL ANIMALS)
No gross internal lesions were observed during necropsy.
HISTOPATHOLOGY (PARENTAL ANIMALS)
No indications of treatment related findings were seen in any of the examined tissues.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Sex:
- male/female
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
No effects were observed on pup viability.
CLINICAL SIGNS (OFFSPRING)
No abnormal effects were observed.
BODY WEIGHT (OFFSPRING)
No treatment related effects were observed on body weight of offspring.
GROSS PATHOLOGY (OFFSPRING)
No external abnormalities or any gross internal lesions were observed.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Sex:
- male/female
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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