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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
Endpoint summary
Administrative data
Description of key information
Oral:
The acute oral toxicity of test item was investigated according to OECD 401.
There was no death and no sign of reaction to treatment. All animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. The acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.
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:
- From 1991-07-26 to 1991-08-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study in accordance with recognised test guideline but: Lot/batch No.: not stated Expiration date of the lot/batch: not stated NOTE: study deemed acceptable because spectral data for test item are available, covering approximately before and after the test period - see section 1.4 Analytical Information.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Purity: Ca. 100%
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: Approximately 5 weeks
- Weight at study initiation: 138 - 155 g for males and 127 - 134 g for females
- Fasting period before study: 18 hours
- Housing:The animals were housed in stainless steel grid cages measuring 54 x 33 x 20 cm (Steven Clarke Fabrications Limited, Alva, Clackmannanshire, Scotland).
- Diet (e.g. ad libitum): Laboratory Animal Diet No. 1 from Biosure, Manea, Cambridgeshire, England, fed ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Target 21ºC, actual range 18º - 25ºC
- Humidity (%): Target 55% RH, actual range 40% - 70% RH
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 26 July 1991 To: 9 August 1991 - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% (w/v) Aqueous Methylcellulose.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5% w/v aqueous methylcellulose
- Amount of vehicle (if gavage): 20 mL / kg
MAXIMUM DOSE VOLUME APPLIED: 2000 mg / kg
DOSAGE PREPARATION (if unusual): The test material was prepared at the appropriate concentration in 0.5% w/v methylcellulose in purified water (obtained through the reverse osmosis of tap water). The dosage was calculated and expressed gravimetrically in terms of the material as received. A fresh formulation of the test material was prepared on the morning of administration and any surplus remaining after dosing was destroyed on the same day.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A preliminary study was carried out using one group of one male and one female rat given a single oral administration of test item at a dosage of 800 mg/kg bodyweight, at a volume-dosage of 20 mL/kg in 0.5% w/v aqueous methylcellulose. There was no death and no sign of reaction to treatment.
On the basis of this result, the main study was carried out using a single group of five male and five female rats given a single oral administration of test item at the maximum practicable dosage of 2000 mg/kg (Regulatory limit test), at a volume-dosage of 20 mL/kg. Since no rat died as a result of treatment the low toxicity of test item was demonstrated and no further groups of animals were employed. - Doses:
- 2000 mg / kg
- No. of animals per sex per dose:
- Five male and five female
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:Twice daily for 15 days, with weighing on day 1, 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gastr-intestinal tract. - Statistics:
- Not applicable
- Preliminary study:
- A preliminary study was undertaken by administering one female rat and one male rat with a single oral dose of 800 mg / kg. There was no death and no sign of reaction to treatment.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No significant pathological findings
- Interpretation of results:
- other: low oral toxicity
- Conclusions:
- Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg / kg.
- Executive summary:
The acute oral toxicity of test item was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg according to OECD 401. The animals were starved overnight prior to dosing. The test material was administered at a volume-dosage of 20 mL/kg in 0.5% w/v aqueous methylcellulose. Mortality and signs of reaction to treatment were recorded during a subsequent 14-day observation period. The animals were killed on the following day and subjected to necropsy.
There was no death and no sign of reaction to treatment. All animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions)
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
Justification for classification or non-classification
Oral LD50: >2000 mg/kg body weight
Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1 , this substance should not be classified for acute toxicity.
Specific target organ toxicity-single exposure:
Oral:
Death: No death at 2000 mg/kg (0/10).
Clinical observations: No signs of reaction to treatment
Body weight: All animals achieved expected bodyweight gains
Macroscopic Findings: Necropsy revealed no significant macroscopic lesion
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should not be classified for this endpoint.
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