Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 616-651-4 | CAS number: 787582-75-6
- 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
One oral and one dermal acute toxicity study were conducted with the test item. Both limit studies showed no mortality, no body weight change and no signs of toxicity. Therefore, the following LD50 values were determined:
oral LD50 (male/female) > 2000 mg/kg bw (reference 7.2.1 -1)
dermal LD50 (male/female) > 2000 mg/kg bw (reference 7.2.3 -1)
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:
- December 22, 2005 - March 31, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 96/54/EC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- GLP compliance:
- yes
- 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
- Weight at study initiation: 157 to 179 g
- Age at study initiation: approx. 6 to 8 weeks
- Fasting period before study: Yes (Diet was withheld from 17 hours before until up to 4 hours after treatment)
- Housing: separately in type III Makrolon cages with a shelter, placed on mobile racks; conventional softwood granulate was used
- Diet: Provimi Kliba 3433.0
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22 °C
- Humidity (%): 51 to 80
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: Aqueous Methocel® K4M Premium solution (2.5 g/L)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: excellent vehicle performance in long range historical data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg bw (limit test)
- 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: clinical signs: at least 6 hours after administration and then checked daily; body weight: before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Body weight: Tox-511 A
- Preliminary study:
- NA
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed. All rats survived the observation period.
- Clinical signs:
- other: No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of the test item.
- Gross pathology:
- At necropsy no organ alterations were seen.
- Other findings:
- None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, it is concluded, that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw following oral treatment in rats.
- Executive summary:
The test item was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw according to OECD TG 423 under GLP conditions. No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw. All rats survived the observation period. Body weight development of the treated rats was inconspicuous. At necropsy no organ alterations were seen.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD TG 423, GLP
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:
- 2007-09-10 to 2007-09-26
- 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:
- 1987-02-24
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 92/69/EC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute 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, DE-33178 Borchen
- Age at study initiation: approx. 9 - 10 weeks
- Weight at study initiation: 201 - 255 g
- Housing: separately
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 23
- Humidity (%): 44 to 70 (The humidity was transiently outside the target range of 45 to 75%. This minor and short deviation did not influence the integrity or the outcome of the study)
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- Backs and abdomens of the rats shaved with electric hair clipper, not later than 1 h before treatment.
Directly before administration test material was moistened with liquid paraffin, spread on the shaven skin, area ca. 6x6 cm, covered with gauze patch, kept in place by self-adhesive fabric. After exposure period of 24 hours gauze and adhesive fabric were removed and any remaining test material wiped off carefully. - 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:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs: at least 6 hours after administration and then checked daily; body weight: on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality - Statistics:
- Body weight data were recorded with the validated PC-program "AKUDAT", statistical evaluations of body weight development carried out with "TOX 511A".
- Preliminary study:
- NA
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the course of the study.
- Clinical signs:
- other: No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Other findings:
- None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, test substance can be considered to have no acute dermal toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.
- Executive summary:
No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg bw according to OECD Guideline 402 under GLP conditions. There were no deaths during the course of the study, so the lethal dose is expected to be higher than the limit dose tested. The body weight development was inconspicuous and the gross pathological examination revealed no organ alterations. Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD TG 402, GLP
Additional information
Acute oral toxicity study
In an acute oral toxicity study, one group of fasted, young adult Wistar rats (3/sex) were given a single oral dose of the test item prepared with aqueous Methocel® K4M Premium solution (2.5 g/L) as vehicle at a dose of 2000 mg/kg bw and observed for 14 days.
The oral LD50 value was determined to be:
Males > 2000 mg/kg bw
Females > 2000 mg/kg bw
Combined > 2000 mg/kg bw
No mortality occurred in this limit test.
There were no treatment related clinical signs, necropsy findings or changes in body weight (reference 7.2.1 -1).
Acute dermal toxicity study
In an acute dermal toxicity study, one group of young adult Wistar rats (5 /sex) were dermally exposed to the test item in liquid paraffin for 24 hours to the shaven body surface area of 6 x 6 cm of at a limit dose of 2000 mg/kg bw. Animals then were observed for 14 days.
The dermal LD50 value was determined to be:
Males > 2000 mg/kg bw
Females > 2000 mg/kg bw
Combined > 2000 mg/kg bw
No mortality occurred in this limit test.
No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg. No deaths occurred during the course of the study. There were no treatment related clinical signs, necropsy findings or changes in body weight (reference 7.2.3 -1).
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for acute oral and dermal toxicity are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not classified for acute toxicity under Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.