Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 April 2008 to 18 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to testing guideline; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): CAE
- Substance type: UVCB
- Physical state: orange to brown liquid
- Purity test date: 23/01/2008
- Lot/batch No.: 1456
- Expiration date of the lot/batch: 18/12/2008
- Stability under test conditions: no information
- Storage condition of test material: at room temperature and away from light
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier (53940 Le Genest-Saint-Isle, France)
- Age at study initiation: about 8 weeks
- Weight at study initiation: 210 ± 6 g
- Fasting period before study: yes
- Housing: polycarbonate cages with stainless steel lid
- Diet (e.g. ad libitum): SSNIFF R/M-H pelleted maintenance diet, ad lib
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/-2°C
- Humidity (%): 50% +/-20%
- Air changes (per hr): 12 cycles per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 April 2008 To: 07 May 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 to 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: forms a solution
- Lot/batch no. (if required): not applicable
- Purity: not indicated
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: as no information on the toxic potential of the test item was available, for animal welfare reasons, the starting dose-level of 300 mg/kg was chosen - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 3 F
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations made regularly the day of treatment and then at least once a day; weight recorded on the day before administration, on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- Not applicable
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality was observed
- Clinical signs:
- 300 mg/kg: none.
2000 mg/kg: Hypoactivity (all the animals) and piloerection (3/6 animals) were noted within 6 hours of treatment. - Body weight:
- 300 mg/kg: When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/3 females between day 8 and day 15, without affecting the mean body weight gain at the end of the study. The body weight gain of the other animals was not affected by treatment with the test item.
2000 mg/kg: When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/6 females between day 1 and day 8 (returning to normal thereafter). The body weight gain of the other animals was not affected by treatment with the test item. - Gross pathology:
- At necropsy, no apparent abnormalities were observed in any animal
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test item CAE was higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, the test item should not be classified. - Executive summary:
The test item CAE was prepared in corn oil and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of three fasted female Sprague-Dawley rats.
The study design was as follows:
Dose-level
(mg/kg)
Volume
(mL/kg)
Female
300
10
3
2000
10
3
2000
10
3
Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item.
All animals were subjected to necropsy.
The interpretation of results was based on the classification critera laid down in Council Directive 67/548/EEC (and subsequent adaptations).
Dose-level of 300 mg/kg (three animals)
No deaths and no clinical signs were observed.
When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/3 females between day 8 and day 15, without affecting the mean body weight gain at the end of the study. The body weight gain of the other animals was not affected by treatment with the test item.
Dose-level of 2000 mg/kg (three females then confirmation on three other females)
No deaths occurred.
Hypoactivity (all the animals) and piloerection (3/6 animals) were noted within 6 hours of treatment.
When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/6 females between day 1 and day 8 (returning to normal thereafter). The body weight gain of the other animals was not affected by treatment with the test item.
At necropsy, no apparent abnormalities were observed in any animal.
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.