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EC number: 285-331-0 | CAS number: 85068-72-0
- 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
Rat Oral LD50: >50 - <300 mg/kg bw (OECD 423, GLP, Rel. 1, K).
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:
- 08 November - 05 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 423 with a minor deviation: temperature was occasionally lower than the optimum value
- 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 was occasionally lower than the optimum value
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- temperature was occasionally lower than the optimum value
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 27 April 2017
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 1000010405
- Date received: 19 October 2017
- Manufacturing date: 10 November 2016
- Expiration date: 15 June 2018
- Purity test date: 20 December 2016
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:
- Sprague-Dawley
- 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: 191-219 g
- Fasting period before study: 1 day
- 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: 30-70%
- Air changes: 10/hour
- Photoperiod: 12 hours dark / 12 hours light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Distilled water was chosen as it produced the most suitable formulation at the requested concentration.
DOSAGE PREPARATION: In the first step of the study, 0.3028 g of the test item was weighed in a flask and distilled water was added to obtain 10.0900 g. The preparation was stirred by vortex to obtain colourless solution just before administration. In the second step of the study, 0.0511 g of the test item was weighed in a flask and distilled water was added to obtain 10.2200 g. The preparation was stirred by vortex to obtain a colourless solution just before administration. In the third step of the study, 0.0528 g of the test item was weighed in a flask and distilled water was added to obtain 10.5646 g. The preparation was stirred by vortex to obtain a colourless solution just before administration. Each preparation was administered under a volume of 10 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal cannula. - Doses:
- 50 and 300 mg/kg bw
- No. of animals per sex per dose:
- 3 and 6 female rats in 300 and 50 mg/kg bw, respectively
- Control animals:
- other: historical data
- 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, 24 hours, and then once daily for 14 days. Animals were weighed on day D0 (just before administering the test item) and then on D2, D7, and D14.
- Necropsy of survivors performed: Yes; animals were euthanized with sodium pentobarbital (Dolethal®) on D14 and macroscopic observations were noted. - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals treated at the dose of 300 mg/kg bw (3/3) were found dead on Day 5. Two mortalities were noted in animals treated at the dose of 50 mg/kg bw on Day 9.
- Clinical signs:
- other: In 300 mg/kg bw group, no clinical signs related to the administration of the test item were observed before the death. Rigor mortis (3/3) and soiled urogenital zone (3/3) were noted before the necropsy. In 50 mg/kg bw group, the mortalities were precede
- Gross pathology:
- - In 300 mg/kg bw group, the macroscopic examination of the dead animals revealed a thinning of forestomach and corpus (3/3) with black spots (3/3), partially red stomach contents (2/3) and dark red liquid in thoracic cavity (2/3).
- In 50 mg/kg bw group, the macroscopic examination of the dead animals revealed red spots in the corpus (2/2) and red spots in a thinning of forestomach (1/2).
- The macroscopic examination of the surviving animals at the end of the study did not reveal treatment related changes. - Other findings:
- None
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 of the test item is higher than 50 mg/kg bw and lower than 300 mg/kg bw by oral route in the rat. In accordance with the OECD Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 200 mg/kg bw by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the Regulation (EC) No. 1272/2008, and according to the Globally Harmonized System of classification and labelling of chemicals (GHS), the test item has to be classified in category 3. The signal word "Danger", symbol “skull and bones” and hazard statement H301 "Toxic if swallowed” are required. - Executive summary:
In an acute oral toxicity study performed according to the OECD Guideline 423 and in compliance with GLP, the test item was administered to a group of 3 female Sprague Dawley rats at the dose of 300 mg/kg bw and then to a group of 6 female Sprague Dawley rats at the dose of 50 mg/kg bw. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.
All animals treated at the dose of 300 mg/kg bw (3/3) were found dead on Day 5. No clinical signs related to the administration of the test item were observed before the death. Rigor mortis (3/3) and soiled urogenital zone (3/3) were noted before the necropsy. The macroscopic examination of the animals revealed a thinning of forestomach and corpus (3/3) with black spots (3/3), partially red stomach contents (2/3) and dark red liquid in thoracic cavity (2/3).
Two mortalities were noted in animals treated at the dose of 50 mg/kg bw on Day 9. The mortalities were preceded on Day 8 by a decrease in spontaneous activity (2/2), muscle tones (2/2), myosis (1/2), piloerection (2/6) and an increase of lachrymation (1/6). Rigor mortis (1/2) and weight loss (1/2) were noted before the necropsy. The macroscopic examination of the animals revealed red spots in the corpus (2/2) and red spots in a thinning of forestomach (1/2).
In the surviving animals (4/6), no clinical signs related to the administration of the test item were observed during the study. 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 treatment related changes.
Rat Oral LD50 >50 - <300 mg/kg bw.
Under the test conditions, the oral LD50 of the test item is higher than 50 mg/kg bw and lower than 300 mg/kg bw by oral route in the rat. In accordance with the OECD Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 200 mg/kg bw by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the Regulation (EC) No. 1272/2008, and according to the Globally Harmonized System of classification and labelling of chemicals (GHS), the test item has to be classified in category 3. The signal word "Danger", symbol “skull and bones” and hazard statement H301 "Toxic if swallowed” are required.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 200 mg/kg bw
- Quality of whole database:
- GLP guideline study
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
In an acute oral toxicity study performed according to the OECD Guideline 423 and in compliance with GLP, the test item was administered to a group of 3 female Sprague Dawley rats at the dose of 300 mg/kg bw and then to a group of 6 female Sprague Dawley rats at the dose of 50 mg/kg bw. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.
All animals treated at the dose of 300 mg/kg bw (3/3) were found dead on Day 5. No clinical signs related to the administration of the test item were observed before the death. Rigor mortis (3/3) and soiled urogenital zone (3/3) were noted before the necropsy. The macroscopic examination of the animals revealed a thinning of forestomach and corpus (3/3) with black spots (3/3), partially red stomach contents (2/3) and dark red liquid in thoracic cavity (2/3).
Two mortalities were noted in animals treated at the dose of 50 mg/kg bw on Day 9. The mortalities were preceded on Day 8 by a decrease in spontaneous activity (2/2), muscle tones (2/2), myosis (1/2), piloerection (2/6) and an increase of lachrymation (1/6). Rigor mortis (1/2) and weight loss (1/2) were noted before the necropsy. The macroscopic examination of the animals revealed red spots in the corpus (2/2) and red spots in a thinning of forestomach (1/2).
In the surviving animals (4/6), no clinical signs related to the administration of the test item were observed during the study. 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 treatment related changes.
Under the test conditions, the oral LD50 of the test item is higher than 50 mg/kg bw and lower than 300 mg/kg bw by oral route in the rat. In accordance with the OECD Test Guideline No. 423, the LD50 cut-off of the test item may be considered as 200 mg/kg bw by oral route in the rat.
Justification for classification or non-classification
The oral LD50 of the registered substance is higher than 50 mg/kg bw and lower than 300 mg/kg bw by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the Regulation (EC) No. 1272/2008, and according to the Globally Harmonized System of classification and labelling of chemicals (GHS), the registered substance has to be classified in category 3. The signal word "Danger", symbol “skull and bones” and hazard statement H301 "Toxic if swallowed” are required.
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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