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Diss Factsheets
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EC number: 200-070-4 | CAS number: 50-89-5
- 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
According to REACH Annex IX, column 1, section 8.7 experimental testing for reproductive toxicity was waived. The available toxicity data indicates no adverse effects on reproductive organs or tissues.
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- 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
According to REACH Annex IX, column 1, section 8.7 experimental testing for reproductive toxicity was waived. The available toxicity data indicates no adverse effects on reproductive organs or tissues.
Effects on developmental toxicity
Description of key information
A combined rat fertility and embryo-fetal development study (combined segments I and II) was carried out according to ICH Harmonised Tripartite Guideline: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2). There were no test article-related changes in male or female fertility following the administration of the test item. No fetal abnormalities were observed.
Link to relevant study records
- Endpoint:
- developmental toxicity
- 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 read-across justification attached.
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guideline: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2)
- Deviations:
- no
- Principles of method if other than guideline:
- Combined rat fertility and embryo-fetal development study (combined segments I and II).
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD)IGS BR
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % (wt/vol)
- Details on exposure:
- - Dosing of males, 28 days prior to cohabitation through the day before completion of cohabitation
- Dosing of females, 15 days prior to cohabitation through gestation day 17 - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Males and females were cohabitated (1:1) for a maximal period of 21 days. Females not mated within the first 14 days of cohabitation were assigned an alternate male rat from the same dose group that had mated and remained in cohabitation for a maximum of seven additional days. Likewise, males not mated within the first 14 days of cohabitation were assigned an alternate female rat and remained in cohabitation for a maximum of three additional days.
- Duration of treatment / exposure:
- Male rats (25 animals/group) were orally administered the test item at doses of 0, 100, 500, or 1,000 mg/kg/day, starting 28 days prior to cohabitation and continuing through the day before the completion of cohabitation. Female rats (25 animals/group) were dosed starting 15 days prior to cohabitation and continuing through gestation day 17. Male rats were sacrificed at the completion of cohabitation, whereas females were sacrificed on gestation day 21.
- Frequency of treatment:
- Daily treatment.
- Duration of test:
- Male treatment was started 28 days prior to cohabitation. Treatment of females was started 15 days prior to cohabitation. Treatment was completed on gestation day 21.
- Remarks:
- Doses / Concentrations:
0, 100, 500 and 1000 mg/kg bw/day
Basis: - No. of animals per sex per dose:
- 25/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Male fertility toxicity was evaluated based on mating and impregnating rate; sperm count, mobility, and morphology; and microscopic examinations of testes and epididymides.
- Ovaries and uterine content:
- Female fertility was evaluated based on estrous cycling, mating and pregnancy rate, number of corpora lutea, number and distribution of implantation sites, early resorption, and microscopic examination of ovaries.
- Fetal examinations:
- Fetotoxicity and teratologic potential were evaluated based on mid and late resorptions; the numbers of live and dead fetuses; external sex; body weight; and gross external alterations and microscopic internal alterations, such as major malformations, minor external visceral and skeletal anomalies, and common skeletal variants.
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: other:
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- In the combined segment I and II study in rats, there were no test article-related changes in male or female fertility following the administration of the test item. No fetal abnormalities were observed.
- Executive summary:
A combined rat fertility and embryo-fetal development study (combined segments I and II) was carried out according to ICH Harmonised Tripartite Guideline: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2). Male fertility toxicity was evaluated based on mating and impregnating rate; sperm count, mobility, and morphology; and microscopic examinations of testes and epididymides. Female fertility was evaluated based on estrous cycling, mating and pregnancy rate, number of corpora lutea, number and distribution of implantation sites, early resorption, and microscopic examination of ovaries. Fetotoxicity and teratologic potential were evaluated based on mid and late resorptions; the numbers of live and dead fetuses; external sex; body weight; and gross external alterations and microscopic internal alterations, such as major malformations, minor external visceral and skeletal anomalies, and common skeletal variants.
There were no test article-related changes in male or female fertility following the administration of the test item. However, the pregnancy rate was 76% in rats dosed at 500 mg/kg/day and 72% in rats dosed at 1,000 mg/kg/day; these rates were slightly lower than that of the control group (92%) but still remained within the historical control range of the testing facility.
In conclusion in this combined segment I and II study in rats, there were no test article-related changes in male or female fertility following the administration of the test item. No fetal abnormalities were observed.
Reference
In the combined segment I and II study in rats, there were no test article-related changes in male or female fertility following the administration of the test item. However, the pregnancy rate was 76 % in rats dosed at 500 mg/kg/day and 72 % in rats dosed at 1000 mg/kg/day; these rates were slightly lower than that of the control group (92 %) but still remained within the historical control range of the testing facility.
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:
- Good quality data base.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available the substance is not classified and labeled according to Regulation 1272/2008/EEC (CLP) and Directive 67/548/EEC (DSD).
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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