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Diss Factsheets
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EC number: 939-248-8 | CAS number: -
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2012 to March 2013
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certificate nr 2011/40 on July 19th 2011
- Limit test:
- no
Test material
- Reference substance name:
- PROCESS OIL
- IUPAC Name:
- PROCESS OIL
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- Females were paired with males from the same dose--level group. One female was placed with one male, in the latter's cage, during the night. Sibling pairings were avoided.
Confirmation of mating was made in the morning by checking for the presence of a vaginal plug or for sperm in a vaginal lavage.
There were no treatment-related effects on mating and fertility data. All animals mated within comparable mean number of days. All females were pregnant, except one in each of the 0, 100, and 300 mg/kg/day groups - Duration of treatment / exposure:
- For males: - 5 weeks
For females: - 2 weeks before paring, during mating and pregnancy, until day 5 post-partum. - Frequency of treatment:
- Daily
- Details on study schedule:
- The chronology of the study is summarized as follows:
Procedure Calendar Date
Study plan approved by
. Study Director 23 October 2012
. Sponsor Representative 05 November 2012
Experimental starting date
(day of arrival of the animals) 25 October 2012
. Identification, weighing and randomization 26 October 2012
First day of treatment 31 October 2012
Mating (day 0 p.c.)
. first females 15 November 2012
. last females 18 November 2012
Functional Observation Battery and motor activity
. males 05 December 2012
. females 11 to 13 December 2012
Hematology and blood biochemistry
. males 06 December 2012
. females 12 to 14 December 2012
Delivery (day 0 p.p.)
. first females 06 December 2012
. last females 09 December 2012
Necropsy date of males 06 December 2012
Necropsy date of females (day 6 p.p.)
. first females 12 December 2012
. last females 15 December 2012
Experimental completion date 11 February 2013
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg/day 0 mg/mL
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
100 mg/kg/day 20 mg/mL
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
300 mg/kg/day 60 mg/mL
Basis:
- Remarks:
- Doses / Concentrations:
1000 mg/kg/day 200 mg/mL
Basis:
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the experimental conditions of the study:
- The No Observed Effect Level (NOEL) for reproductive performance was considered to be 1000 mg/kg/day in the absence of any treatment-related effect on mating and fertility at this dose-level.
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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