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EC number: 296-229-0 | CAS number: 92368-90-6
- 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
The acute oral LD50 was established to be greater than 5000 mg/kg bw.
The acute dermal LD50 was > 5000 mg/kg bw in rats.
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:
- 1985-05-24 to 1985-06-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: male: 91-113 g, female: 102-112 g
- Housing: up to 5 animals per dose per sex in polypropylene cages
- Diet: ad libitum, no food over night before treatment and 2 h after treatment, Rat & Mouse Expanded Diet No. 1, supplied by Special Diet Services Limited, Witham, Essex
- Water: ad libitum, tap water
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45-66
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2.5, 20, 200, 500 mg/mL
- Amount of vehicle: 10 mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL - Doses:
- 25, 200, 2000, 5000 mg/kg bw
- No. of animals per sex per dose:
- 2 for range finding test, 5 for main study
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed 0.5, 1, 2, 3, 4, 5 h and afterwards once per day after treatment. The bodyweight was measured on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ - Statistics:
- No data provided.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One male animal (5000 mg/kg bw) died between day 2 and 3.
- Clinical signs:
- other: Hunched posture and pilo erection were observed in all rats and all dose levels. Diarrhoea was observed in single rats at 25 and 200 mg/kg bw levels. Respiratory decrease (≥ 200 mg/kg bw), lethargy and increased salvivation (≥ 2000 mg/kg bw) were observed
- Gross pathology:
- Animal that died: congestion of the lungs, ulceration and haemorrhage of glanular region of the stomach and haemorrhage of intestinal tract
Animals sacrified: No macroscopic abnormalities - Other findings:
- No other observations were made.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute oral toxicity study in rats was conducted. The acute oral LD50 was established to be greater than 5000 mg/kg bw.
- Executive summary:
An acute oral toxicity using the standard acute method according to OECD 401 was performed with rats. 25, 200, 2000 and 5000 mg/kg bw of the test substance were administered to rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. All dose levels of the test substance produced signs of toxicity like a hunched posture and piloerection. Other signs like lethargy and increased salivation were observed for high doses only. The animals were symptom free starting from day 2 after treatment. One animal of the dose group 5000 mg/kg bw died between day 2 and 3. Due to these results the test substance was considered to be practically nontoxic and the oral LD50 > 5000 mg/kg bw was derived for rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available study is sufficient for assessment.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-05-24 to 1985-06-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-12 weeks
- Weight at study initiation: male: 324-353 g, female: 275-286 g
- Housing: individually for 24 h after exposure; up to 5 animals per dose per sex in polypropylene cages
- Diet: ad libitum, no food over night before treatment and 2 h after treatment, Rat & Mouse Expanded Diet No. 1, supplied by Special Diet Services Limited, Witham, Essex
- Water: ad libitum, tap water
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45-66
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: hair clipped dorsal, lateral and ventral regions (6 x 12 cm)
- % coverage: 10 % of complete body surface
- Type of wrap if used: 7 x 4 cm patch of surgical gauze, strip of elastic adhesive bandage wrapped around the trunk of the animal twice
REMOVAL OF TEST SUBSTANCE
- Washing: skin and surrounding hair were sponged thoroughly with warm water, rinsed and dried using absorbant paper
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 50 mg/kg bw (0.05 mL/kg), 400 mg/kg bw (0.43 mL/kg), 2000 mg/kg bw (2.13 mL/kg), 5000 mg/kg bw (5.32 mL/kg)
- Concentration: undiluted
- Constant volume or concentration used: yes, several animals were treated with constant concentrations and for within each concentration group a constant volume was used - Duration of exposure:
- 24 h
- Doses:
- 50, 400, 2000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 2 for range finding test, 5 for main study
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2, 3, 4 and 5 h after application and afterwards at least once per day. The body weight was measured on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: Animals showed no observable response to treatment.
- Gross pathology:
- No abnormalities detected.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute dermal toxicity study in rats was performed. The animals showed no signs of toxicity and therefore it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.
- Executive summary:
An acute dermal toxicity study in rats was performed according to OECD 402 with 50, 400, 2000 and 5000 mg/kg bw of the test substance. One female rat showed a small weight loss in the first week and reduced weight gain in the second week, while all other animals showed a normal weight gain. No mortality was observed and the animals showed no signs of toxicity. Due to these results it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available study is sufficient for assessment.
Additional information
Acute toxicity:
Oral route
An acute oral toxicity using the standard acute method according to OCED 401 was performed with rats. 25, 200, 2000 and 5000 mg/kg bw of the test substance were administered to rats by gavage. They were observed for 14 days and afterwards sacrificed and necropsy was performed. All dose levels of the test substance produced signs of toxicity like a hunched posture and piloerection. Other signs like lethargy and increased salivation were observed for high doses only. The animals were symptom free starting from day 2 after treatment. One animal of the dose group 5000 mg/kg bw died between day 2 and 3. Due to these results the test substance was considered to be practically nontoxic orally and the oral LD50 > 5000 mg/kg bw was derived for rats.
Dermal route
An acute dermal toxicity study in rats was performed according to OECD 402 with 50, 400, 2000 and 5000 mg/kg bw of the test substance. One female rat showed a small weight loss in the first week and reduced weight gain in the second week, while all other animals showed a normal weight gain. No mortality was observed and the animals showed no signs of toxicity. Due to these results it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity via oral and dermal route, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in Regulation (EU) No 2016/918.
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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