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EC number: 418-370-0 | CAS number: 143925-92-2
- 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 test item did not induce acute toxicity after oral and dermal application at 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:
- 1995-05-19 to 1995-07-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: young adult albino rats
- Weight at study initiation: 172 to 223 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: relative humidity of 55 ± 10 %.
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hour/day light cycle. - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight - Doses:
- 2000 mg/kg bpody weight
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily for 14 days; Body weight: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- NA
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in this study.
- Clinical signs:
- other: Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application.
- Gross pathology:
- At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Upon single oral administration of 2000 mg/kg to male and female rats (Limit test) and a 14 day post-treatment observation period, an LD50 of greater than 2000 mg/kg was determined for the test item.
- Executive summary:
In an oral toxicity study according to OECD guideline 401, 5 rats per sex were dosed once with the test article in arachis oil by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortalities were recorded. Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application. Body weight was not affected by the treatment. At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found. The oral LD50 value of the test article in rats was established to exceed 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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:
- 1995-06-06 to 1995-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: young adult albino rats
- Weight at study initiation: 201 to 230 g
- Fasting period before study: none
- Housing: individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: relative humidity of 55 ± 10%
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hour/day light cycle - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10 % of body surface
- Type of wrap: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with luke warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg
- Concentration: 500 mg/mL
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied: 4 mL/kg bw
- Concentration: 500 mg/mL - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily for 14 days; Body weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- NA
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in this study.
- Clinical signs:
- other: No signs of acute dermal toxicity were observed in this study.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- At 2000 mg/kg the test item elicited no signs of acute toxicity in male and female rats.
- Executive summary:
In a GLP-compliant acute dermal toxicity study (OECD 402), the test article in oleum arachidis was administered to five male and five female rats by dermal application at 2000 mg/kg body weight for 24 hours. The test article was evenly dispersed on the skin covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. No signs of acute dermal toxicity were observed in this study and animals showed normal body weight gain. At necropsy, no deviations from normal morphology were found. In conclusion, the dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral
In a GLP-compliant acute oral toxicity study (OECD 401), the test substance in arachis oil was administered by oral gavage to five rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred in this study. Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application. Body weight was not affected by the treatment. At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found. Therefore, the oral LD value in male and female rats was established to exceed 2000 mg/kg body weight.
Dermal
In a GLP-compliant acute dermal toxicity study (OECD 402), the test article in oleum arachidis was administered to five male and five female rats by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. No signs of acute dermal toxicity were observed in this study and animals showed normal body weight gain. At necropsy, no deviations from normal morphology were found. In conclusion, the dermal LD50 value in rats was established to exceed 2000 mg/kg body weight.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No 1272/2008,as amended for the eighth time in Regulation (EU) No 2016/218.
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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