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Diss Factsheets
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EC number: 268-952-1 | CAS number: 68155-26-0
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Read across approach adequate to support 7.8.2 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017)
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Read across approach adequate to support 7.8.2 according to "Guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals" (ECHA 2008) and Read-Across Assessment
Framework (RAAF) (ECHA 2017) - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- between day 6 and 15 of gestation
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg diet
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 800 mg/kg bw/day
- Dose / conc.:
- 1 200 mg/kg bw/day
- Control animals:
- yes
- Details on study design:
- The rats were killed on day 20 and the uteri examined for number of implantation sites and for live and dead implantations.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Rats receiving 500 mg/kg bw or higher doses either died or were in a moribund condition and were killed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weight gain was reduced in the 200-mg/kg bw group,
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOEL
- Effect level:
- 1 200 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no effects
- Developmental effects observed:
- no
none of the gestational parameters in the
treated groups was significantly different from those of the controls. No fetal abnormalities at the max. tested concentration.Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- Reference substance 003
- Cas Number:
- 68603-42-9
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 20 days
- Frequency of treatment:
- days from 6 to 15 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw (total dose)
- Dose / conc.:
- 100 mg/kg bw (total dose)
- Dose / conc.:
- 300 mg/kg bw (total dose)
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- Control animals:
- yes
- Details on study design:
- 25 Controls were dosed with arachis oil. The dams were killed on day 20 of gestation
Examinations
- Maternal examinations:
- no death in the group
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Salivation and propulsion of the head was observed in all test groups; salivation was “severe” in the 1000 mg/kg group
Maternal developmental toxicity
- Description (incidence and severity):
- Post-implantation loss and total embryonic deaths were statistically significantly increased in all treated groups compared to the controls; these findings were considered incidental by the researcher because one single female accounted for these findings in each group
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: no effects
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Retardation of ossification was statistically significantly increased in the 300 and 1000 mg/kg groups; again, the researcher found this effect to be incidental because the values were within the normal range of variation for this strain. The incidence of ossification of the skull bones was statistically significantly increased in the 1000 mg/kg group; two dams accounted for 10 of the 17 findings in this group.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: no effects
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.