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EC number: 610-623-5 | CAS number: 511540-64-0
- 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
acute toxicity, oral (OECD 423, RL1), rats (m/f): LD50 > 2000 mg/kg bw
acute toxicity, dermal (OECD 402, RL1), rats (f): LD50 > 2000 mg/kg bw
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:
- 07 Jun 2006 - 14 Aug 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: about 6-7 weeks
- Weight at study initiation: 158 - 180 g (range)
- Fasting period before study: yes, overnight (17 hours before - 4 h after treatment)
- Housing: the rats were housed in an air-conditioned room of ca. 25 m² in the Institute of Toxicology in Macrolon cages type III with a shelter, placed on mobile racks. Animals were kept on conventional softwool granulate as bedding which was changed 2x per week.
- Diet: Provimi Kliba 3433.0, ad libitum
- Water: tap water from Makrolon drinking bottles, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 45-75
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
Directly before the preparation the test metariel was solved in the vehicle using a shaking device (Vortex Genie) and and Ultra Turrax device.
The vehicle chosen was Methocel(R) K4M Premium solution (Batch ZDP 24/2006 and 26/2006, stable until June 30 and July 14 2006)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
The behaviour and general condition of all animals was monitored for at least 6 h after administration of the test material and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes, all surviving animals were sacrificed at the end of the experimental period by CO2 asphyxia and subjected to gross pathological investigation. - Statistics:
- Body weight data were recorded with the PC software "akudat", the statistical evaluation of the body weight were carried out with the software "Tox 511A", the body weight development of each rat and group was determined. The group mean value was calculated for each measurement.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality during the study period.
- Clinical signs:
- other: No clinical signs were observed during the study period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, it is concluded that the test item has no acute toxic potential and the the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.
- Executive summary:
The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw. Directly before administration the test material was prepared with aqueous Methocel Premium Solution as the vehicle. The study was performed according to OECD Guideline 423.
No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. The body weight development was inconspicuous. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.
Based on the results of this study, it is concluded that the test item has no acute toxic potential and the the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.
Reference
Table 1: Mortality and clinical signs during the study period
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males & Females |
||||
2000 |
0/0/6 |
--- |
--- |
0 |
LD50 > 2000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- OECD Guideline study under GLP conditions
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 20, 2020 - November 10, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- October 9, 2017
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: no
- Age at study initiation: 13 - 14 weeks
- Weight at study initiation: 224 - 254 g
- Fasting period before study:
- Housing: Single-housed in type III Makrolon cages with a shelter and a play tunnel on softwood bedding material overnight. Because no clinical symptoms were seen one day after treatment the rats were group-housed again in type IV Makrolon cages until end of the observation period.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.0 - 24.1°C
- Humidity (%): 42.7 - 55.3%
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10% of the total body surface area
- Type of wrap if used: Patch (polypropylene nonwoven) was fixed with a tape (Fixomull stretch)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- For solids, paste formed: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15.
- Necropsy of survivors performed: yes
- Clinical signs including body weight - Preliminary study:
- Due to the chemical properties of the test item, mortality after dermal administration was not expected at the highest starting dose of 2000 mg/kg bw. Therefore, the range-finding study was started in 1 female rat with 2000 mg/kg bw.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- No organ alterations were identified.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item has no acute dermal toxic potential under the conditions of the present study, and the LD50 value in rats exceeds 2000 mg/kg bw after single dermal administration.
- Executive summary:
The objective of the present study was to identify potential toxic effects of the test item after single dermal administration to rats in a stepwise procedure.
The study was started with a dose-range finding study using one femae rat treated with 2000 mg/kg bw. Due to the fact, that no mortality was seen after treatment with 2000 mg/kg bw, two further females were treated with 2000 mg/kg bw in the main study.
Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
No mortality occurred during the course of this study. No clinical signs of toxicity were observed. The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations.
The LD50 value of the test item was determined to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- OECD Guideline study under GLP conditions
Additional information
Acute oral toxicity
The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw. Directly before administration the test material was prepared with aqueous Methocel Premium Solution as the vehicle. The study was performed according to OECD Guideline 423.
No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. The body weight development was inconspicuous. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.
Based on the results of this study, it is concluded that the test item has no acute toxic potential and the the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.
Acute dermal toxicity
The objective of the present study was to identify potential toxic effects of the test item after single dermal administration to rats in a stepwise procedure.
The study was started with a dose-range finding study using one femae rat treated with 2000 mg/kg bw. Due to the fact, that no mortality was seen after treatment with 2000 mg/kg bw, two further females were treated with 2000 mg/kg bw in the main study.
No mortality occurred during the course of this study. No clinical signs of toxicity were observed. The body weight development was inconspicuous throughout the study. The gross pathological examination revealed no organ alterations.
The LD50 value of the test item was determined to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
The available data on acute oral and dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008.
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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