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EC number: 912-666-8 | 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:
- key study
- Study period:
- From July 5 1994 to July 19 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: four to seven weeks of age
- Weight at study initiation: 94-113 g
- Housing: in groups of up to five rats of the same sex in metal cages
- Diet: ad libitum, but it was prevented overnight prior to and approximately 4 hours after dosing
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 68
- Air changes (per hour): 10-15
- Photoperiod (hours dark / light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methylcellulose
- Details on oral exposure:
- The test material was prepared at a concentration of 20% w/v in 1% w/v aqueous methylcellulose and administered at a volume of 10 ml/kg bodyweight.
The test substance was prepared on the day of dosing. - Doses:
- 2.0 g/kg bodyweight
- No. of animals per sex per dose:
- A group of ten rats (five males and five females)
- Control animals:
- no
- Details on study design:
- OBSERVATIONS
Mortality
Cages of rats were checked a least twice daily for any mortalities.
Clinical signs
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of fine hours). On subsequent days (with the exception of Day 15 – morning only) animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16:30 hours on week days or 11:30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing.
Bodyweight
The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes were calculated.
TERMINAL STUDIES
Termination
All were killed on Day 15 by cervical dislocation.
Macroscopic pathology
All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all tissues was recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single oral dose of the test substance at 2.0 g/kg bodyweight.
- Clinical signs:
- Piloerection was observed in all rats within five minutes of dosing. This sign persisted throughout Day 1 and much of Day 2. There were no other clinical sign and recovery, as judged by external appearance and behavior, was complete by the second observation on Day 2.
- Body weight:
- All rats achieved anticipated bodyweight gains throughout the study.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
Any other information on results incl. tables
Individual bodyweights (g) of rats dosed orally
Bodyweight (g) at | |||||
Sex | Dose (g/kg) | Animal number & ear mark | Day 1 | Day 8 | Day 15 |
Male | 2 | 1 RP | 113 | 195 | 265 |
2 LP | 100 | 179 | 237 | ||
3 RPLP | 101 | 167 | 221 | ||
4 RIRO | 95 | 170 | 222 | ||
5 LILO | 94 | 166 | 221 | ||
Female | 2 | 6 RP | 107 | 152 | 179 |
7 LP | 109 | 160 | 193 | ||
8 RPLP | 98 | 147 | 179 | ||
9 RIRO | 103 | 147 | 182 | ||
10 LILO | 102 | 150 | 182 |
Individual bodyweight changes (g) of rats dosed orally with the test substance
Bodyweight (g) at | ||||
Sex | Dose (g/kg) | Animal number & ear mark | Week 1 | Week 2 |
Male | 2 | 1 RP | 82 | 70 |
2 LP | 79 | 58 | ||
3 RPLP | 66 | 54 | ||
4 RIRO | 75 | 52 | ||
5 LILO | 72 | 55 | ||
Female | 2 | 6 RP | 45 | 27 |
7 LP | 51 | 33 | ||
8 RPLP | 49 | 32 | ||
9 RIRO | 44 | 35 | ||
10 LILO | 48 | 32 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal oral dose to rats of the test substance was found to be greater than 2.0 g/kg bodyweight..
- Executive summary:
A study was performed to assess the acute oral toxicity of the test substance to the rat. The method followed was that described in the OECD Guideline for Testing of Chemicals No. 401.
A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, formulated in 1% w/v aqueous methylcellulose, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.
There were no deaths. Clinical signs of reaction to treatment were confined to piloerection, recovery was complete by the second observation on day 2. All rats achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal oral dose to rats of the test substance was found to be greater than 2.0 g/kg bodyweight.
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