Registration Dossier
Registration Dossier
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: 700-300-8 | 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The procedures used comply with the requirements of the OECD Guideline for Testing of Chemicals No. 420, 1992, and Commission Directive 92/69/EEC, B.1 bis, 1992.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- reaction mass of Lycopyl salt isomers in Methanol
- IUPAC Name:
- reaction mass of Lycopyl salt isomers in Methanol
- Details on test material:
- - Name of test material (as cited in study report): (2E,4E,6E)-(3,7,11-Trimethyl-dodeca-2,4,6,10-tetraenyl)-triphenyl-phosphonium acetate
- Physical state: clear yellow liquid
- Analytical purity: not available
- Lot/batch No.: P19-39.5
- Expiration date of the lot/batch: 19 December 1996
- Storage condition of test material: In refrigerator at 2-8 °C, protected from light, covered with Nitrogen
- Other: Date of receipt 28 August 1996
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, England
- Age at study initiation: 4-7 weeks
- Weight at study initiation:
- Fasting period before study: overnight fasting
- Housing: Animals were housed in groups of up to five, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays.
- Diet (e.g. ad libitum): pelleted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): Main drinking water in polypropylene bottles were freely available.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 44-61
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 and 100 mg/mL at dose volume of 20 mL, 50 mg/mL at dose volume of 10 mL (range finding) and 25 mg/mL at dose volume of 20 mL (main test) - Doses:
- 500, 1000, 2000 mg/kg bodyweight (range finding test)
500 mg/kg bodyweight (main test) - No. of animals per sex per dose:
- three females (range finding test)
five females, five males (main test) - Control animals:
- no
- Details on study design:
- In the range finding test, test article at dose levels of 500, 1000, or 2000 mg/kg bodyweight was administered once only by gavage to 3 female rats which had benn fasted overnight. All animals were weighed on the day of dosing to permit the calculation of the dose volume to be administered. Surviving animals were weighed on day 8. Dose levels were administered sequentially with at least 24 hours between the administration of one dose level and the next; the dose level selected being dependent on the results of treatment with the previous one.
Animals were observed immediately after dosing, and 30 minutes, one, 2 and 4 hours after dosing for signs of toxicity or abnormal behaviour. Observations were made daily thereafter for a furhter 7 days.
The range finding study indicated that 500 mg/kg was the highest dose that could be administered without causing mortality. The main study was therefore conducted at this level using groups of five female and five male rats.
Animals were fasted overnight before dosing. The test article was administered as a single dose by gavage. After dosing animals were returned to their cages and permitted access to food. Observations were made shortly after administration and 30 minutes, one, 2 and 4 hours after dosing. Animals were examined daily thereafter during 14 days. Bodyweights were determined before dosing and on days 2,3,4,8 and 15. All animals were weighed and than killed at the end of day 15 and a necropsy was done for all animals.
Results and discussion
- Preliminary study:
- The animal treated with 2000 mg/kg was found dead on day 2. Effects observed in the animal treated with 1000 mg/kg included hypoactivity, piloerection, hunched posture, perbuccal staining, unsteady on feet and a red discharge from eyes noted after 5 hours after dosing. In the animal treated with 500 mg/kg, piloerection was observed from 30 minutes after dosing until day 2, salivation was noted 30 and 60 minutes after dosing, and noisy breathing was noted on day 7 and 8.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: maximum tolerated oral dose
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Mortality:
- No deaths occurred.
- Clinical signs:
- One female rat exhibited noisy breathing on days 2,3,4 and 5 only. There were no clinical signs of toxicity throughout the observation period in the remaining animals.
- Body weight:
- There was no adverse effect on overall bodyweight gain in animals of either sex.
- Gross pathology:
- No treatment related findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Treating with the test article at a dose level of 5000 mg/kg bodyweight to a group of 5 male and 5 female rats produced clinical signs of toxicity but no deaths. The result of this study indicate that the maximum tolerated oral dose lies between 500 and 2000 mg/kg bodyweight.
- Executive summary:
The purpose of the study was to assess the acute oral toxicity of the test article, Ro 44 -9567/002 in the rat using the Fixed Dose Method according to OECD Guideline No. 420.
The results of a rangefinding study indicated that a dose level of 2000 mg/kg bodyweight caused death and dose levels of 500 or 1000 mg/kg produced apparent signs of toxicity but no deaths. As a dose level of 500 mg/kg bodyweight was the highest of the fixed doses that could be adminisitered without causing mortality, the main study was conducted at this dose level. The test article was administered as a single oral dose by gavage to a group of five male and five female rats which had been fasted overnight. The animals were examined frequently on the day of dosing and daily thereafter for a further 14 days at the end of which, they were killed and subjected to necropsy.
In the main study, following oral administration of a dose level of 500 mg/kg bodyweight, no deaths occurred and all animals maintained a healthy appearance with the exception of 1 female rat which exhibited noisy breathing on days 2,3,4 and 5 only. There was no adverse effect on overall bodyweight gain in animals of either sex. No treatment related findings were observed at necropsy.
Treatment with the test article, Ro 44 -9567/002, at a dose level of 500 mg/kg bodyweight to a group of five male and five female rats produced clinical signs of toxicity but no deaths. The results of this study indicate that the maximum tolerated oral dose lies between 500 and 2000 mg/kg bodyweight.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.