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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
- 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:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is conducted according to the current guideline and in accordance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats of SPF quality.
15 air changes per hour
temperature 19-25
relative humidity 30-70%
12-hour light/12 hour dark cycle. - Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on mating procedure:
- Animals were mated from the 15th day of study. Each morning the females were examined for prescence of spermatozoa in veginal smears. Day 0 of pregnancy was defined as the day the sperms were found.
- Duration of treatment / exposure:
- both sex - 14 days prior to the mating period +
males - 14 days during and after the mating period (totally for 28 days)
pregnant females - during pregnancy and till 3rd day of lactation
nonpregnant females - for 25 days after the confirmed mating
14 days prior to the mating period
14 days during the mating period - Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
160 mg/kg of body weight/day
Basis: - Remarks:
- Doses / Concentrations:
400 mg/kg of body weight/day
Basis: - Remarks:
- Doses / Concentrations:
1000 mg/kg of body weight/day
Basis: - No. of animals per sex per dose:
- 12 males and 12 females
3 doses+1 control group (48 males+48 females completely) - Control animals:
- yes
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: The value is based on the incidence of atrophic changes in prostate gland.
- Remarks on result:
- other: Generation: No data (migrated information)
- Reproductive effects observed:
- not specified
- Conclusions:
- The test substance pigment yellow 191 was evaluted in reproduction/developmental screening test. The NOAEL based on the study results was concluded to be 1000 mg/kg bw/day (rat;male/female).
- Executive summary:
In the dose-range finding experiment with the test substance changes of body weight gain were not observed in treated males and females. No treatment related adverse effects on animal health or behavior of animals were observed at any dose level. Results of haematological examination showed changes in white blood cells in females at the dose levels 500 and 1000 mg/kg/day. Pathological examination revealed only changes related to colour of the test substance at the dose levels 500 and 1000 mg/kg/day. No animal died during the 14-day application period.
The study was conducted according to OECD guideline 421 and in compliance of GLP.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 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
Reproduction/Developmental Toxicity Screening Test (OECD Guideline 421) was performed to obtain information about test substance related adverse effects on fertility of parental animals or possible adverse effects on development of pups. The test was performed in accordance with GLP.
In the dose-range finding experiment no body weight changes were observed in treated males and females when compared to untreated controls. Health condition control and clinical observation did not detect adverse impact on clinical status and behaviour of animals at any dose level. Results of haematological examination showed the test substance influenced on white blood cells in females at the dose levels 500 and 1000 mg/kg/day. Pathological examination revealed only changes related to colour of the test - at the dose levels 500 and 1000 mg/kg/day. No animal died during the 14-day application period.
The influence of the test substance treatment was observed mainly at the highest dose level (limit dose) – decrease of absolute and relative weight of prostate gland and occurrence of atrophic changes in prostate gland of parental males. The changes relating to prostate gland at the dose level 1000 mg/kg were considered of effect related to the test substance (without negative influence on fertility of parental males).
Reproductive performance – ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. Also development of pups was not changed in treatment groups.
Short description of key information:
For the test substance, following values of reproduction toxicity were found:
The NOEL (No Observed Effect Level) for the toxic effect on reproduction organs of males was established as 400 mg/kg body weight/day (the value is based on the incidence of atrophic changes in prostate gland).
The NOEL (No Observed Effect Level) for the toxic effect on reproduction organs of females was established as 1000 mg/kg body weight/day.
The NOAEL (No Observed Adverse Effect Level) for REPRODUCTION was established as 1000 mg/kg body weight/day.
Justification for selection of Effect on fertility via oral route:
The reliable guideline compliant study.
Effects on developmental toxicity
Description of key information
The NOAEL (No Observed Adverse Effect Level) for development of pups was established as 1000 mg/kg body weight/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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
Reproduction/Developmental Toxicity Screening Test (OECD Guideline 421) was performed to obtain information about test substance related adverse effects on fertility of parental animals or possible adverse effects on development of pups. The test was performed in accordance with GLP.
In the dose-range finding experiment no body weight changes were observed in treated males and females when compared to untreated controls. Health condition control and clinical observation did not detect adverse impact on clinical status and behaviour of animals at any dose level. Results of haematological examination showed the test substance influenced on white blood cells in females at the dose levels 500 and 1000 mg/kg/day. Pathological examination revealed only changes related to colour of the test - at the dose levels 500 and 1000 mg/kg/day. No animal died during the 14-day application period.
The influence of the test substance treatment was observed mainly at the highest dose level (limit dose) – decrease of absolute and relative weight of prostate gland and occurrence of atrophic changes in prostate gland of parental males. The changes relating to prostate gland at the dose level 1000 mg/kg were considered of effect related to the test substance (without negative influence on fertility of parental males).
Reproductive performance – ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. Also development of pups was not changed in treatment groups.
Justification for selection of Effect on developmental toxicity: via oral route:
The reliable guideline compliant study
Justification for classification or non-classification
No reproduction or developmental toxicity was observed at the highest tested dose level (1000 mg/kg bw/day) and therefore no classification required according to the CLP Regulation (EC) 1272/2008 and EU Directive 67/548/EEC.
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.
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