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EC number: 610-949-8 | CAS number: 53045-70-8
- 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
The test item was tested for acute toxicity in rats after oral administration of 300 and 2000 mg/kg body weight. The rats treated with 300 mg/kg survived until the end of the observation period, whereas all rats treated with 2000 mg/kg died 50 minutes up to 23 hours after dosing. Signs of toxicity were seen in the rats treated with 300 mg/kg immediately after oral administration up to 60 minutes. They consisted of locomotor disturbance, dyspnoea, and one female rat showed abdominal position. According to the results of this study with the test item, the LD50 value was determined to be between 300 – 2000 mg/kg falling into category 4 based on GHS criteria.
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:
- July 25, 2006 - December 01, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 12-2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 09-1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdCpb:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 156 - 174 g
- Fasting period before study: 17 hours before until up to 4 hours after dosing
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 51 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From days 1 to 15 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- Methocel® K4M Premium solution
- Details on oral exposure:
- Dose volume: 10 or 2.37 mL/kg
The test was started with 2000 mg/kg. Therefore at the dose of 2000 mg/kg the liquid test material was administered undiluted. At the dose of 300 mg/kg the test material volume of the undiluted test material was minimal. Therefore the test material was prepared directly before administration with aqueous Methocel® K4M Premium solution as the vehicle. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 300 mg/kg: 3 m / 3 f
2000 mg/kg: 3 f - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes (gross pathology) - Statistics:
- Standard statistical methods have been applied for data processing.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg: 0/3 m, 0/3 f
2000 mg/kg: 3/3 f - Clinical signs:
- other: 300 mg/kg: Signs of toxicity were seen immediately after dosing up to 60 minutes after dosing. They consisted of locomotor disturbance, dyspnoea, and one female rat showed abdominal position. 2000 mg/kg: All rats died within 50 minutes to 23 hours after d
- Gross pathology:
- All male and female rats dosed with 300 mg/kg were sacrificed at the end of the study. They exhibited no macroscopic abnormalities at necropsy except for one male rat with focal white discolorations in liver and spleen. At histology no abnormalities were detected in these organs.
In rats dosed with 2000 mg/kg gross pathology revealed fluid matter in the stomach in all these rats. In one rat this matter was ill malodorous and pungent combined with mucosal swelling. At histology a submucosal oedema with some granulocytes was diagnosed in this rat combined with moderate autolysis. In the two other rats a massive autolysis of the stomach or a single cell necrosis of epithelial cells and increased amounts of viable and degenerating neutrophilic granulocytes in the lamina propria were detected. All findings are related to the local irritating properties of the test item at high concentrations. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- For regulatory purposes, the median lethal dose (LD50) can be declared between 300 - 2000 mg/kg.
- Executive summary:
Study design
The test item was tested for acute toxicity in rats after oral administration of 300 and 2000 mg/kg body weight. The test was started with 2000 mg/kg. Therefore at the dose of 2000 mg/kg the liquid test material was administered undiluted. At the dose of 300 mg/kg the test material volume of the undiluted test material was minimal. Therefore the test material was prepared directly before administration with aqueous Methocel® K4M Premium solution as the vehicle. This GLP study was performed according to the "Acute toxic class method" (ATC) as described in the OECD GL 423.
Results
The rats treated with 300 mg/kg survived until the end of the observation period, whereas all rats treated with 2000 mg/kg died 50 minutes up to 23 hours after dosing. Signs of toxicity were seen in the rats treated with 300 mg/kg immediately after oral administration up to 60 minutes. They consisted of locomotor disturbance, dyspnoea, and one female rat showed abdominal position. The body weight development was inconspicuous. In rats treated with 2000 mg/kg clinical signs were seen immediately after oral administration up to the end of the first observation day. They consisted of salivation, abdominal position, locomotor disturbance, and dyspnoea. Gross pathology and histopathology did not reveal any abnormalities in rats treated with 300 mg/kg. Rats treated with 2000 mg/kg revealed fluid matter in the stomach, which was malodorous and pungent in one animal. Beside autolysis, histology revealed signs of acute inflammation (oedema, neutrophilic infiltration) which was most pronounced in the animal which survived for 23 hours. All findings are considered to be related to local irritating properties of the test item at high concentrations.
Conclusion
According to the results of this study with the test item, the LD50 value is expected to be between 300 – 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 300 - < 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:
- July 25, 2006 - September 22, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 02-1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 12-1992
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdCpb:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 11 weeks
- Weight at study initiation: 222 - 248 g
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 51 - 68
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From days 1 to 15 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The backs and abdomens of the rats were shaved with an electric hair clipper not later than one hour before treatment. The test material (2.37 mL/kg) was spread on the shaven skin in an area of 6*6 cm and covered with a gauze patch. This was kept in place by a self-adhesive fabric. The time of exposure was 24 hours. Then the gauze and adhesive fabric were removed and any remaining test material was wiped off carefully
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 m / 5 f
- Control animals:
- no
- Details on study design:
- Observation for clinical symptoms: On the day of treatment the general condition and motility of the rats were slightly affected by the tape. It was difficult to distinguish between slight clinical findings and reactions due to fixation by the tape. The behaviour and general condition of all rats were monitored for at least 6 hours after administration and then checked daily.
Bodyweight: All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
Pathology: All rats were sacrificed at the end of the experimental part and subjected to a gross pathological investigation. - Statistics:
- Standard statistical methods have been applied for data processing.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- All rats survived the observation period.
- Clinical signs:
- other: No signs of toxicity were detected in any rat.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this GLP study performed according to OECD GL 402, the test item was tested for acute toxicity in rats after dermal administration of 2000 mg/kg. Based on the result of this study, the test item can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg.
- Executive summary:
Study design
In this GLP study performed according to OECD GL 402, the test item was tested for acute toxicity in rats after dermal administration of 2000 mg/kg. The liquid test material was spread on the shaven skin in an area of 6*6 cm and covered with a gauze patch, which was kept in place by a self-adhesive fabric. The time of exposure was 24 hours, then the gauze and adhesive fabric were removed and any remaining test material was wiped off carefully.
Results
No signs of toxicity were detected and there were no deaths during the course of the study. The body weight development was inconspicuous and also the gross pathological examination revealed no organ alterations.
Conclusion
Based on the result of this study, the test item can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for selection of acute toxicity – oral endpoint
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 423.
Justification for selection of acute toxicity – dermal endpoint
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 402.
Justification for classification or non-classification
Based on the provided information the substance is classified as acute toxic category 4 according to the EU Regulation (EC) No 1272/2008 on Classification,Labelling and Packaging of Substances and Mixtures.
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