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EC number: 247-952-5 | CAS number: 26741-53-7
- 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
Description of key information
To examine reprotoxicity of the test item a one generation study was conducted (no GLP, equivalent to OECD guideline 415). Male and female rats were administered at doses of 100 and 500 ppm for 12 weeks (fed in diet). At a dose of 100 ppm in the rat the product has no effect on fertility, whilst at the dose of 500 ppm a reduction in fertility of about 20% was observed. According the authors, the background variation is about 10% and these results are bordering on insignificance. The NOAEL for fertility is therefore considered to be 500 ppm (compound intake not given, therefore no calculation of mg/kg bw).
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- yes
- Remarks:
- only two doses used; only 15 animals per dose used, reporting details
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Weston XP 1452
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: animals weighing about 50 g
- Housing: two animals per cage
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 26 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
It was preferred to use the product in conditions close to its utilization, i.e. being heated in plastics. For practical mixing reasons and for technical reasons, the product was mixed with the food which was shaped into small biscuits in accordance with the normal preparation technique for rats' diets; the product was therefore heated. - Details on mating procedure:
- The animals were mated at the rate of 8 males selected at random from each group for 15 females from each group. After 3 weeks, the females were separated and placed in individual cages. At birth, the number of young per litter was counted and each litter was weighed and days 1, 10 and 20. The young were examined for any possible malformation of limbs or palate or hydrocephalus.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- daily
- Dose / conc.:
- 100 ppm
- Dose / conc.:
- 500 ppm
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, plain diet
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality in any case of treated or untreated animals was observed.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Growth was normal.
- 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
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Description (incidence and severity):
- The number of gravid females was identical in the control group and the treated group receiving food containing 100 ppm of the test substance. However, we noted a reduction in fertility of 20% in the case of the diet containing 500 ppm of test substance, although the results are bordering on insignificance.
- Dose descriptor:
- NOAEL
- Effect level:
- 100 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no adverse findings
- Dose descriptor:
- LOAEL
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The weight of the young was reduced at 500 ppm.
- 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
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse finding at this level
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
To examine reprotoxicity of the test item a one generation study was conducted (no GLP, equivalent to OECD guideline 415). Male and female rats were administered at doses of 100 and 500 ppm for 12 weeks (fed in diet). The animals were mated at the rate of 8 males for 15 females. After 3 weeks, the females were separated and placed in individual cages. At birth, the number of young per litter was counted and each litter was weighed an days 1, 10 and 20. The young were examined for any possible malformation of limbs or palate or hydrocephalus. Mortalities did not occur, growth was considered to be normal. A reduction in fertility of 20% in the high dose group was noted. Fertility in the low dose group was not impaired. According the authors, the background variation is about 10% and these results are bordering on insignificance. The NOAEL for fertility is therefore considered to be 500 ppm (compound intake not given, therefore no calculation of mg/kg bw).
Effects on developmental toxicity
Description of key information
A teratogenicity study in rabbits (equivalent to OECD guideline 414) was conducted to determine toxicity to mother and embryo. The test material was administered by gavage at dose levels of 20, 50, 200 mg/kg bw from day 6 -18 of gestation. Application of the test item to gestating rabbits did not induce maternal toxicity. Sex ratio, implantation as well as number and weight of the foetuses was not affected by the treatment. Miscarriages (3/15) were observed at the high dose group. This result is bordering on insignificance and was therefore disregarded. In conclusion, the test material is not considered to be teratogenic.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Species:
- rabbit
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
A teratogenicity study in rabbits (equivalent to OECD guideline 414) was conducted to determine toxicity to mother and embryo. The test material was administered by gavage at dose levels of 20, 50, 200 mg/kg bw from day 6 -18 of gestation. Caesarian section and examination for malformations was performed on day 29 of gestation. Application of the test item to gestating rabbits did not induce maternal toxicity. Sex ratio, implantation as well as number and weight of the foetuses was not affected by the treatment. Food consumption was normal in all of the groups. The product does not affect the frequency of distribution of yellow bodies or implantation in the uterus or the number of live foetuses, and the distribution between male and female foetuses is normal. At 200 mg/kg bw, there was a slight reduction in the weight of the foetuses (insignificant). Any notable sign of malformation in the foetus were not observed. In the high dose group, 3 rabbits miscarried on days 18, 20 and 23 p.c. This result is bordering on insignificance and was therefore disregarded. In conclusion, the test material is not considered to be teratogenic.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008.
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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