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EC number: 444-090-3 | CAS number: 204848-45-3
- 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
The test item was not tested itself. Two structural analogues were tested in a reproduction/developmental toxicity screening test in rats (according to OECD 421 and 422, GLP). According to these studies, the NOAEL for parental toxicity and for reproductive performance (mating and fertility) was considered to be 1000 mg/kg bw/day, which was the highest dose tested.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No signs of test substance toxicity at a dosage of 1000 mg/kg bw/d applied (high dose equals limit dose)
- Remarks on result:
- other: CAS 31274-51-8
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related adverse effects observed up to and including the highest dose level of 1000 mg/kg bw
- Remarks on result:
- other: CAS 446824-06-2
- Critical effects observed:
- no
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No test substance related effects were observed on pups after birth, at a dosage of 1000 mg/kg bw/d applied (high dose equals limit dose)
- Remarks on result:
- other: CAS 31274-51-8
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related adverse effects observed up to and including the highest dose level of 1000 mg/kg bw
- Remarks on result:
- other: CAS 446824-06-2
- Critical effects observed:
- no
- Reproductive effects observed:
- no
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
- Quality of whole database:
- Read across sources according to OECD TG 421/422, GLP, Klimisch 1/2
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Procedure and observations
Regarding toxicity to reproduction, there are no data of the test substance itself. Reliable experimental data on two read across substance are available (see justification attached to IUCLID section 7.8.1 and 13):
In a GLP-conform study according to OECD guideline 421, the structural analogue (CAS 446824-06-2) was administered orally by gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg body weight/day (corn oil served as vehicle), 100 mg/kg bw/d, 300 mg/kg bw/d and 1000 mg/kg bw/d. The duration of treatment covered a 2-week premating and a mating period in both sexes, approximately 1 week post-mating in males, and the entire gestation period as well as 4 days of lactation and 2 weeks thereafter in females. A detailed clinical observation was performed in all animals. Body weights and food consumption were determined in F0 animals. All animals were assessed by gross pathology; weights of selected organs were recorded and a histopathological examination was performed. Clinical examinations, reproductive performance, clinical pathology, histopathology and gross pathology did not reveal any finding in treated animals. Viability, sex ratio and body weight of the pups was not affected. Examination of the ovaries and the uterine content did not overt any effect on uterus weight, number of implantations or resorptions.
In accordance with OECD guideline 422 and GLP, a combined repeated dose toxicity study with a reproduction/developmental toxicity screening test was performed using a formulation containing the structurally analogue substance CAS 31274-51-8 (47.6 % active substance). Three groups of 10 male and 10 female Sprague-Dawley rats received the test item formulation daily, by oral gavage administration before mating, through mating and, for the females, through gestation until day 4 post-partum, at dose-levels of 210, 1050 and 2100 mg/kg bw/d (equivalent to dose-levels of 100, 500 and 1000 mg/kg bw/d of the test item, respectively). Two other groups of 10 males and 10 females received either the vehicle (purified water) or placebo (respective formulation without test item) alone, under the same experimental conditions and acted as control groups. The dosing volume was 5 mL/kg bw/day. The litters were sacrificed on day 5 post-partum. At all dose-levels with the test item, treatment-related mortalities or clinical signs of toxicity did not occur. There were no effects on mean body weight gain or food consumption of males or females compared to the control group given purified water; however, when compared to the placebo control group the females had higher body weight gains and food consumption. Adverse effects did not occur based on hematology, blood biochemistry or urinalysis parameters. Estrous cycling, pairing, mating or fertility were not adversely affected in any dose-group and pups showed no effects after birth in any group. Test item-related effects did not occur on organ weights and macroscopic abnormalities were not apparent. Microscopic examination revealed aggregates of large histiocytes in the bronchioles of two females of the 1000 mg/kg/day dose-group, an effect attributed to accidental aspiration of the dosing mixture subsequent to administration and not to the test item directly.
Conclusion
Under the conditions of the previously described Reproduction/Developmental Toxicity Screening Tests, the oral administration of two analogue substances by gavage to male and female Wistar rats did not reveal signs of toxicity. Thus, the NOAEL for parental toxicity, for reproductive performance (mating and fertility) and for developmental toxicity is 1000 mg/kg bw.
Due to the high comparability to the two structural analogues, the same outcome can be expected for CAS 204848-45-3.
Effects on developmental toxicity
Description of key information
The test item was not tested itself. Two structural analogues were tested in a reproduction/developmental toxicity screening test in rats (according to OECD 421 and 422, GLP) and the NOAEL for developmental toxicity was found to be 1000 mg/kg bw/day, which was the highest dose tested.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: No treatment-related adverse effects observed up to and including the highest dose level of 1000 mg/kg bw
- Remarks on result:
- other: CAS 446824-06-2 (OECD 421)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: No signs of test substance toxicity at a dosage of 1000 mg/kg bw/d applied (high dose equals limit dose)
- Remarks on result:
- other: CAS 31274-51-8 (OECD 422)
- Key result
- Abnormalities:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No treatment-related adverse effects observed up to and including the highest dose level of 1000 mg/kg bw
- Remarks on result:
- other: CAS 446824-06-2 (OECD 421)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No test substance related effects were observed on pups after birth, at a dosage of 1000 mg/kg bw/d applied (high dose equals limit dose)
- Remarks on result:
- other: CAS 31274-51-8 (OECD 422)
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
Reference
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
- Quality of whole database:
- Read across sources according to OECD TG 421/422, GLP, Klimisch 1/2
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
Please refer to section "Effects on fertility - Additional information" within this endpoint summary
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available screening study is reliable and suitable for classification purposes under Regulation 1272/2008. No adverse effects on fertility or development were observed in screening studies in rats (OECD 422/421). As a result, the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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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