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EC number: 205-459-2 | CAS number: 141-12-8
- 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
In accordance with a study conducted according to Guideline OECD 423, the oral LD50 of the test substance can be considered > 5000 mg/kg bw in rats.
In accordance with a study conducted according to Guideline OECD 402, the dermal LD50 of the test substance is > 5000 mg/kg bw in rabbit.
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:
- 04-25 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 423 with minor deviations: temperature and relative humidity were occasionally lower than the minimum optimum values
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- dated 17 December, 2001
- Deviations:
- yes
- Remarks:
- temperature and relative humidity were occasionally lower than the minimum optimum values
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- temperature and relative humidity were occasionally lower than the minimum optimum values
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 23 October 2015
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 171893
- Date received: 22 April 2016
- Manufacturing date: 10 December 2015
- Expiry date: 09 December 2017
- Purity test date: 10 December 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Fridge (6 ± 3°C), darkness
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Used as supplied - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS, France
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 or 9 weeks
- Weight at study initiation: 180-219 g
- Fasting period before study: Food was removed on Day 1 and then redistributed 4 hours after the test item administration.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): Foodstuff (ENVIGO - 2016), ad libitum
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-25°C
- Humidity: 17-70%
- Air changes: At least 10/hour
- Photoperiod: 12 hours dark / 12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION: In the first and the second step of the study, the test item was administered by gavage under a volume of 2.20 mL/kg bw (corresponding to 2000 mg/kg bw, according to the density of 0.911 g/mL supplied by the Sponsor) using a suitable graduated syringe fitted with an oesophageal metal canula.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality were recorded at 30 minutes, 1 hour, 3 hours, 4 hours, and then once daily for 14 days. Animals were weighed on Day 0 (just before administering the test item) and then on Day 2, Day 7 and Day 14.
- Necropsy of survivors performed: Yes; animals were euthanized with sodium pentobarbital on Day 14 and macroscopic observations were noted. - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: A decrease in spontaneous activity (2/6), Preyer’s reflex (1/6) and muscle tone (3/6) was noted in the first hours of the test. The animal recovered a normal activity at 24-hour post-dose.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is > 2000 mg/kg bw in rats. In accordance with OECD Guideline 423, the LD50 cut-off of the test substance may be considered to be > 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the Globally Harmonised System on classification and labelling of chemicals (GHS). No signal word or hazard statement is required.
- Executive summary:
In an acute oral toxicity study performed according to Guideline OECD 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was given by oral gavage to a group of 6 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days.
No mortality occurred during the study. A decrease in spontaneous activity (2/6), Preyer’s reflex (1/6) and muscle tone (3/6) was noted in the first hours of the test. The animals recovered a normal activity at 24-hour post-dose. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment related changes.
Rat Oral LD50 > 2000 mg/kg bw.
Therefore, the oral LD50 of the test substance is > 2000 mg/kg bw in rats. In accordance with Guideline OECD 423, the LD50 cut-off of the test substance may be considered to be > 5000 mg/kg bw by oral route in the rat. Therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the Globally Harmonised System for classification and labelling of chemicals (GHS). No signal word or hazard statement is required.
Reference
None
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:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Standard acute method: Test substance at three dose levels was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) for 24 hours. Animals were then observed for dermal reactions, food consumption, body weights and general behaviour for 14 days.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Label on test material: RIFM 71-10-56 1-13-72 - Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: Individually housed in metabolism cages
- Diet (e.g. ad libitum): Rabbit pellets, ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three centimeters, longitudinally, over the clipped area of exposure. The abrasions were sufficiently deep so that they penetrated the stratum corneum bot not the dermis, so that no bleeding occurred.
- Type of wrap if used: Application areas were covered with a rubber sleeve or dam which fit snuggly around each animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Application sites were thoroughly wiped down.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0, 3.9 and 6.0 mL/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2.0, 3.9 and 6.0 mL/kg bw
- No. of animals per sex per dose:
- 4 rabbits/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Examinations performed: During the observation period each animal's food consumption, body weights and general behavior were recorded. Before beginning of the test and at the end of the observation period, haematology and urinalysis were performed on all surviving animals.
- Necropsy of survivors performed: No - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 6 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: All animals remained normal throughout the study.
- Gross pathology:
- Not applicable
- Other findings:
- - Dermal reactions: Application sites on the back did not show any erythema or oedema and remained normal throughout the study.
- Food consumption: All animals consumed their daily ration and behaved normal throughout the study.
- Haematology: A comparison of the initial and final haematogram values of each animal did not reveal any significant changes. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the test substance is > 5000 mg/kg bw in rabbits therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the GHS.
- Executive summary:
In an acute dermal toxicity study, 2.0, 3.9 or 6.0 mL/kg bw of the test substance was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) for 24 hours. Animals were then observed for dermal reactions, food consumption, body weights and general behaviour for 14 days.
All animals consumed their daily ration, gained weight and behaved as normal laboratory acclimatized animals. Application sites on the back did not show any erythema or oedema and remained normal throughout the study. A comparison of the initial and final haematogram values of each animal did not reveal any significant changes.
Rabbit dermal LD50 > 6 mL/kg bw (equivalent to 5466 mg/kg bw, considering 0.911 g/mL as the density of the test substance).
Therefore, the dermal LD50 of the test substance is > 5000 mg/kg bw in rabbits and it is not classified according to Regulation (EC) No 1272/2008 and according to the GHS.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
In an acute oral toxicity study performed according to Guideline OECD 423 and in compliance with GLP, a single dose of 2000 mg/kg bw of the test substance was given by oral gavage to a group of 6 female Wistar rats. Animals were then observed for mortality and clinical signs of toxicity for 14 days.
No mortality occurred during the study. A decrease in spontaneous activity (2/6), Preyer’s reflex (1/6) and muscle tone (3/6) was noted in the first hours of the test. The animals recovered a normal activity at 24-hour post-dose. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal any treatment related changes.
In an acute dermal toxicity study, 2.0, 3.9 or 6.0 mL/kg bw of the test substance was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) for 24 hours. Animals were then observed for dermal reactions, food consumption, body weights and general behaviour for 14 days. All animals consumed their daily ration, gained weight and behaved as normal laboratory acclimatized animals. Application sites on the back did not show any erythema or oedema and remained normal throughout the study. A comparison of the initial and final haematogram values of each animal did not reveal any significant changes. Rabbit dermal LD50 > 6 mL/kg bw (equivalent to 5466 mg/kg bw, considering 0.911 g/mL as the density of the test substance).
Justification for classification or non-classification
The oral LD50 of the test substance is > 2000 mg/kg bw in rats and the dermal LD50 of the test substance is > 5000 mg/kg bw in rabbits. In accordance with Guidelines OECD 423 and OECD 402, the LD50 cut-off of the test substance may be considered to be > 5000 mg/kg bw by oral route in the rat and by derma route in the rabbit. Therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the Globally Harmonised System for classification and labelling of chemicals (GHS). No signal word or hazard statement is required.
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