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EC number: 228-845-2 | CAS number: 6362-79-4
- 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
Adequate acute oral gavage studies in rats and mice were identified. An adequate acute dermal toxicity study in rats has been performed.
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although conducted prior to current protocol or GLP requirements, the study conformed to recognized protocols current at the time.
- Principles of method if other than guideline:
- Performed prior to current protocol or GLP requirements but by a method acceptable at the time.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Male and female rats were given an aqueous solution of the test substance by gavage.
- Doses:
- 3200 mg/kg bwt
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 3 200 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 3 200 mg/kg bw
- Mortality:
- One of four male and one of four female rats died.
- Clinical signs:
- other: Clinical signs included prostration, diarrhea, rough hair coat, depressed appetite, and slight to moderate weakness post dosing.
- Conclusions:
- The LD50 value of the test substance in male and female rats was greater than 3200 mg/kg bwt.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 200 mg/kg bw
- Quality of whole database:
- Reliable studies in rats and mice were identified.
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:
- October 3, 2013 - October 17, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Food and Agricultural Materials Inspection Centre (FAMIC), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar strain, Crl:WI (Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (males: 297-342 g; females: 204-233 g)
- Housing: Individually in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: October 3, 2013 - October 17, 2013 - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- - Clipping: One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped
- Application: The formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
- Frequency: Single dosage, on Day 1
- Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at WIL Research Europe and on test substance data supplied by the sponsor.
Dose volume: 2000 mg/kg (10 mL/kg) body weight.
DOSAGE PREPARATION: The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15
(only the results of the clinical observation on Day 5 were not recorded, but the study integrity was not affected, since sufficient data was available)
- Necropsy of survivors performed: Yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred
- Mortality:
- No mortality occurred
- Clinical signs:
- other: - Chromodacryorrhoea (snout) was noted in the majority of animals between Days 1 and/or 2 (grade 1) - Yellow discoloration of the treated skin site was noted in all animals during the observation period
- Gross pathology:
- Macroscopic examination of the animals did not reveal any abnormalities.
- Other findings:
- None reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD/EC test guidelines, the LD50 >2000 mg/kg bw was determined for the substance.
- Executive summary:
The acute dermal toxicity of the substance was determined in the rat, in accordance with OECD 402 (1987) and according to GLP principles. The substance was administered to five Wistar rats of each sex by a single dermal application of 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Chromodacryorrhoea (snout) was noted in the majority of animals between Days 1 and/or 2 (grade 1), as well as yellow discoloration of the treated skin site in all animals during the observation period. Incidences of slight body weight loss or reduced body weight gain were seen in females during the first week post treatment. Macroscopic examination of the animals did not reveal any abnormalities. The dermal LD50 value of the substance in Wistar rats was established to be >2000 mg/kg bw. Based on the results, the substance does not have to be classified for acute dermal toxicity according to the CLP Regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute Oral Toxicity
In an acute oral gavage study (water vehicle) in groups of male and female rats (4/sex), a single male and female rat dosed at 3200 mg/kg bw died. Clinical signs included protration, diarrhea, rough hair coat, depressed appetite, and slight to moderate weakness post dosing. The LD50 value in male and female rats was > 3200 mg/kg bw. In another study in rats (10/group), animals dosed by gavage (water vehicle) at dose levels ranging from 200 to 3200 mg/kg bw were not affected. The LD50 for this study was reported as > 3200 mg/kg bw. In another acute oral study in mice (10/group), animals dosed by gavage (water vehicle) at dose levels ranging from 200 to 3200 mg/kg bw were not affected.
Acute Dermal Toxicity
The acute dermal toxicity of the substance was determined in the rat, in accordance with OECD 402 (1987) and according to GLP principles. The substance was administered to five Wistar rats of each sex by a single dermal application of 2000 mg/kg bw for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Chromodacryorrhoea (snout) was noted in the majority of animals between Days 1 and/or 2 (grade 1), as well as yellow discoloration of the treated skin site in all animals during the observation period.Incidences of slight body weight loss or reduced body weight gain were seen in females during the first week post treatment. Macroscopic examination of the animals did not reveal any abnormalities. The dermal LD50 value of the substance in Wistar rats was established to be >2000 mg/kg bw.
In acute dermal toxicity studies, groups of 3 guinea pigs were exposed to a water solution of the subject material under occlusive wrap for a 24 -h exposure period. Slight skin irritation was noted but no mortality up to the limit dose of 1000 mg/kg bw.
Acute Toxicity: Other Routes
Groups of 10 rats were administered a 10% solution of the subject material in water by intraperitoneal injection at doses ranging from 200 to 3200 mg/kg bw. Mortality occurred from 1 to 7 days following exposure. Clinical signs in affected animals included weakness, prostration, labored respiration, tremors, and rough coats. The LC50 in the study was reported as 800 mg/kg bw. Groups of 10 mice were administered a 10% solution of the subject material in water by intraperitoneal injection at doses ranging from 200 to 3200 mg/kg bw. Mortality occurred from 1.5 h to 3 days following administration. Clinical signs in affected animals included weakness and rough coat. The LC50 reported in this latter study was 400 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
No adverse effects were noted in acute oral gavage studies in mice and rats.
Justification for selection of acute toxicity – dermal endpoint
An adequate acute dermal toxicity study in rats has been performed.
Justification for classification or non-classification
In a reliable oral acute toxicity study in experimental animals, there was no significant toxicity noted. Thus, no classification for acute toxicity is warranted. Also, no classification for STOT (single) is warranted.
Based on the performed acute dermal toxicity study, the substance does not have to be classified for acute dermal toxicity according to the CLP Regulation.
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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