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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 (OECD 401), rat: LD50 > 5000 mg/kg bw
Dermal (OECD 402), rat: LD50 > 5000 mg/kg bw
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:
- 01 - 23 May 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No information on purity was given.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no information on purity
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 4 - 6 weeks
- Weight at study initiation: 120 - 152 g (males), 107 - 137 g (females)
- Fasting period before study: overnight prior to dosing until approx. 2 h after dosing
- Housing: 5 animals of the same sex per cage in polypropylene cages on sawdust
- Diet: Rat & Mouse Expanded Diet No. 1 (Special Diet Services Limited, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 ± 2.5
- Humidity (%): 45 - 60
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- A range-finding study was carried out to establish a dosing regimen for the main study.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- Range-finding study: 25, 200, 2000 and 5000 mg/kg bw
Main study: 5000 mg/kg bw - No. of animals per sex per dose:
- Range-finding study: 2
Main study: 5 - Control animals:
- no
- Details on study design:
- Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed 0.5, 1 and 4 h after administration and subsequently once daily for 7 days.
Main study:
- 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 administration and subsequently once daily for 14 days. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period of the range-finding study and the main study.
- Clinical signs:
- other: Range-finding study: Abnormal body carriage (hunched posture) and pilo-erection were observed in all rats at all dose levels. Lethargy and ataxia were seen in rats at the 2000 mg/kg bw dose level and above while ptosis and a decreased respiratory rate wer
- Gross pathology:
- Post mortem examination of all rats killed at Day 14 revealed congestion of the lungs in two rats only. No macroscopic abnormalities were observed in any of the remaining animals.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.
- Executive summary:
An acute oral toxicity study was performed with male and female rats according to OECD 401 under GLP conditions. After a range-finding study with the dose levels 25, 200, 2000 and 5000 mg/kg bw, a main study with 5000 mg/kg bw was performed. No mortality occurred during the study period of the range-finding study and the main study.
In this acute oral toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
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:
- 22 May - 17 June 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No information on purity was given.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- No information on purity was given.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 10 - 12 weeks
- Weight at study initiation: 262 - 285 g (males), 237 - 264 g (females)
- Housing: individually during the 24 h exposure period and subsequently up to 5 animals of the same sex per cage in polypropylene cages on sawdust
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45 - 66
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: skin of the dorsal, lateral and ventral regions (6 cm x 12 cm)
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a surgical gauze patch (7 cm x 4 cm) which was held in place with a strip of elastic adhesive bandage (7.5 cm wide and 25-30 cm long) wrapped around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: The 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
- Amounts applied: 0.06, 0.46, 2.29 and 5.71 mL/kg bw (range-finding study); 5.71 mL/kg bw (main study)
- Constant concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- Range-finding study: 50, 400, 2000 and 5000 mg/kg bw
Main study: 5000 mg/kg bw - No. of animals per sex per dose:
- Range-finding study: 2
Main study: 5 - Control animals:
- not required
- Details on study design:
- Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed 30 min and 1 and 4 h after administration and subsequently once daily for 7 days.
Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 3, 4 and 5 h after administration and subsequently at least once daily for 14 days. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes - Preliminary study:
- No deaths or clinical signs of toxicity were noted up to the highest concentration tested throughout the 7-day observation period. The dose level selected for the main study was therefore 5000 mg/kg bw.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No signs of systemic toxicity were noted until the end of the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.
- Executive summary:
An acute dermal toxicity study was performed with male and female rats according to OECD 402 under GLP conditions. After a range-finding study with the dose levels 50, 400, 2000 and 5000 mg/kg bw, a main study with 5000 mg/kg bw was performed. No mortality occurred during the study period of the range-finding study and the main study.
In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was derived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2). This study is not a standard information requirement set out in Annex VII of Regulation (EC) No 1907/2006 and is thus considered as additional information.
Additional information
Acute oral toxicity
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 401 and in compliance with GLP (1985). Based on a preliminary study, groups of 5 male and female rats were given a dose level of 5000 mg/kg bw via gavage. No mortality occurred during the study period up to concentrations of 5000 mg/kg bw. Signs of toxicity were observed in all rats treated with the test substance shortly after dosing, completely recovered by Day 2. Thus, a LD50 > 5000 mg/kg bw for male and female rats was determined.
Acute dermal toxicity
The acute dermal toxicity of the test substance was assessed in a study according to OECD Guideline 402 and in compliance with GLP (1985). Based on a preliminary study, groups of 5 male and female rats were treated with the test substance at a concentration of 5000 mg/kg bw. No mortality or signs of toxicity occurred during the study period. Thus, a dermal LD50 > 5000 mg/kg bw for male and female rats was determined.
Justification for classification or non-classification
The available data on acute oral and dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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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