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EC number: 500-301-1 | CAS number: 111870-68-9 1 - 6.5 moles propoxylated
- 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
Description of key information
In a fixed dose procedure 5 female rats received a single dose of 2000 mg/kg bw of an analogue substance by gavage. Rats were observed for 14 days thereafter. No mortality occurred. One female showed hunched posture, ataxia, noisy respiration, increased salivation and lethargy during the first day. The other females showed hunched posture during the first 2 hours after dosing. There were no effects on body weight and no macroscopic findings. Based on these findings the oral LD50 of the substance is > 2000 mg/kg bw.
As the analogue substance is of low acute oral toxicity, is not classified as STOT SE and there are no other signs of systemic toxicity, the acute dermal toxicity study has been waived. As the inhalation exposure route is not relevant for this substance no acute study via the inhalation route is included.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 November 2017 to 27 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Strain: RccHan™:WIST
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 164-188 g
- Fasting period before study: overnight before dosing and 3-4 hours after dosing
- Housing: solid-floor polypropylene cages furnished with woodflakes (maximum 4/cage)
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: solubility, substance was not soluble in water or arachis oil
MAXIMUM DOSE VOLUME APPLIED: 10 mL
- Doses:
- 2000 mg/kg bw 1 female
2000 mg/kg bw 4 additional females - No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality: twice daily (once in weekends)
clinical signs: 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days
bodyweight: day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- NA
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: in the first female on day 1: hunched posture, ataxia, noisy respiration, increased salivation and lethargy other females: during first 2 hours after dosing: hunched posture
- Gross pathology:
- no abnormalities observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the substance is > 2000 mg/kg bw
- Executive summary:
In a fixed dose procedure 5 female rats received a single dose of 2000 mg/kg bw by gavage. Rats were observed for 14 days thereafter. No mortality occurred. One female showed hunched posture, ataxia, noisy respiration, increased salivation and lethargy during the first day. The other females showed hunched posture during the first 2 hours after dosing. There were no effects on body weight and no macroscopic findings. Based on these findings the oral LD50 of the substance is > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No studies on Castor oil, hydrogenated, propoxylated are available. In view of the structural and physico-chemical similarities between the source and the target chemical, the toxicity of Castor oil, hydrogenated, ethoxylated is considered to be representative for the toxicity of the target substance.
As the structural analogue substance is of low acute oral toxicity, is not classified as STOT SE and there are no other signs of systemic toxicity, the acute dermal toxicity study has been waived. As the inhalation exposure route is not relevant for this substance no acute study via the inhalation route is included.
Justification for classification or non-classification
Based on the available information no classification for acute toxicity is necessary according to Regulation (EC) No 1272/2008 (CLP).
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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