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EC number: 411-080-5 | CAS number: -
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- A reproduction/developmental toxicity screening test in rats to assess general toxicity and potential effects on fertility of the F0 generation as well as potential effects on pre- and early postnatal development of the F1 generation after oral exposure was conducted in compliance with the OECD Guideline for Testing of Chemicals, Section 4: Health Effects No. 421 „Reproduction/Developmental Toxicity Screening Test“, adopted July 27, 1995
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Test Item: Bayplast Gelb G Gran
Synonymes: Pigment Yellow FC 26290
Chemical name: 2-[[5-amino-3-methyl-1-(3-sulfophenyl)- 1H-pyrazol-4-yl]azo]-4,5-dichloro-benzenesulfonic acid, calcium salt 1:1
CAS No.: 111071-53-5
Molecular Mass (g/mol): 544.4 g/mol
Content(s): 86.4%
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- The F0 animals were pretreated with the test substance for 2 weeks prior to the cohabitation period. During the following cohabitation period the first F0 male was co-housed with the first female F0 animal within the group and so on over night (afternoon up to next morning) at a planned maximum of 14 times during the two-week cohabitation period. As a rule inseminated females were not further co-housed. Insemination was established by investigating vaginal smears prepared in the morning after co-housing or by occurrence of a vaginal plug.
- Duration of treatment / exposure:
- females: 57 days
males: 36 days - Frequency of treatment:
- The test substance or vehicle was administered daily to the animals from the first day of the study until the day before scheduled necropsy.
- Duration of test:
- 57 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 or 1000 mg/kg body weight
Basis:
actual ingested
- No. of animals per sex per dose:
- 12 male and 12 female Wistar rats per dose group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity.
Evaluation of Implantation Sites in F0 Females
Dose No. of Implantation Sites Total No. of Pups at Birth Prenatal Loss
mg/kg per Litter Total Means per Litter
0 14.50 116 106 10
100 14.91 164 150 14
300 12.86 90 84 6
1000 14.60 146 133 13
F1 Litter Parameters at Birth and Viability
The total numbers of pups born, stillborn pups, the live birth index, percentage of males born, the litter size at birth and the viability index were not affected by treatment
Dose Number of Pups Live Birth Males Mean Litter Viability on Day 4 p.p.
mg/kg Total Dead Index % % Size 1) %
0 106 8 92.86 53.06 12.25 91.07
100 150 0** 100.00 51.79 13.64 98.64
300 84 5 94.51 58.92 11.29 94.64
1000 133 0** 100.00 45.99 13.30 100.00
1) viable pups only
Clinical Observations in F1 Pups
No clinical signs with a dose-dependent distribution were observed in F1 pups during the five days lactation.
The following findings were considered as spontaneous findings: Several animals of the control group were cold to touch and did not reveal a milk spot. At 100 mg/kg, paleness was observed in one animal and one animal did not reveal a milk spot.
Body Weights of F1 Pups
The weights at birth and on day 4 p.p. of pups were not relevantly changed
Pup Weights in g
Dose in mg/kg Sex Day 0 p.p. Day 4 p.p.
0 m 6.89 11.64
100 m 6.82 11.52
300 m 7.03 12.59
1000 m 7.12 11.81
0 f 6.57 11.28
100 f 6.49 11.23
300 f 6.72 12.28
1000 f 6.79 11.40
Gross Pathological Changes in F1 Pups
No macroscopical alterations with a remarkable incidence or dose-dependency were noted at pup necropsies.
Autolysis of parts of the body was observed in few animals. This included 2 control pups (Nos. 9 and 12) as well as 3 pups in the mid dose group (Nos. 10, 11 and 12).
Applicant's summary and conclusion
- Executive summary:
Bayplast Gelb G Gran (Pigment Yellow FC 26290_CAS no 111071-53-5)was administered daily via gavage in 0.9% aqueous sodium chloride solution to 12 male and 12 female Wistar rats per dose group, in doses of 0, 100, 300 or 1000 mg/kg body weight. Treatment started 2 weeks prior to mating and continued during the mating period of up to 2 weeks. Males were dosed further up to necropsy for a total period of at least 4 weeks and females were dosed during gestation and lactation up to their necropsy on day 4-6 post partum.
Investigations were performed on general tolerance of the test compound by the parental animals as well as on effects on reproduction including early postnatal development of F1 pups. The animals were regularly observed and weighed, food intake and reproduction parameters were determined. Selected organs were weighed and organs were subjected to macroscopical and histopathological investigations.
The compound did not result in any signs of parental toxicity. The yellow discoloration of the content of the gastro-intestinal tract was a consequence of the administration of the strongly coloured test compound. Body weight and food consumption were not affected. Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity.
In conclusion, 1000 mg/kg represents the NOEL for male and female reproductive function and for developmental toxicity.
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