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EC number: 941-129-0 | CAS number: 1407974-32-6
- 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
The oral LD50 of the test item in female rats has been determined to be greater than 2000 mg/kg bw.
The dermal LD50 in rats was determined to be > 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:
- 12 November 2013 to 05 December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD test guideline method.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: RccHan : WIST(SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V. Horst, The Netherlands
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 193.4 to 213.7g
- Fasting period before study: Overnight
- Housing: Makrolon Type 4 cages
- Diet (e.g. ad libitum): Teklad Rat-Mouse diet 2914C ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 6 to 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): >30%
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
IN-LIFE DATES: From: 12 November 2013 To: 05 December 2013 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The LD50in rats is
>5000 mg/kg body weight (based on data from components or similar materials), therefore the
starting dose was set at 2000 mg/kg body weight. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily during acclimatization; prior to treatment, within the first 30 minutes and approximately 1, 2, 3
and 5 hours after treatment on test day 1; once daily during test days 2 - 15. Body weights were taken at start of acclimatization, on test day 1 (prior to treatment), 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed.
- Preliminary study:
- A preliminary study was performed in a single animal at 2000 mg/kg body weight.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No intercurrent deaths occured during the course of the study.
- Clinical signs:
- other: After treatment on test day 1, 2 of 5 animals (animal nos. 2 and 3) showed ruffled fur at all observation time points (within 0.5 h and at 1, 2, 3 and 5 hours). From test day 2 onwards, no clinical signs were observed in any animal.
- Gross pathology:
- No macroscopic findings wererecorded at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of the test substance after single oral administration to female rats, observed over a period of 14 days, is: LD50(female rat): greater than 2000 mg/kg body weight.
- Executive summary:
Test Guidance
The acute toxicity of the test substance when administered by a single oral gavage to rats was investigated according to OECD test guideline No. 420 and Commission Regulation (EC) No. 440/2008, B.1.
Method
To determine the dose level for the main study, one sighting study was conducted with one female RccHan:WIST (SPF) rat. The animal was treated with the test item at a dose level of 2000 mg/kg body weight by single oral gavage administration. The test item was formulated in Polyethylene glycol 300 (PEG 300) at a concentration of 0.2 g/mLand administered at a dosing volume of 10 mL/kg body weight. Since no mortality occurred in the animal dosed at 2000 mg/kg, four additional females were treated at this dose level in the main study. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2 - 15. Mortality/viability was recorded before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during testdays 2 - 15. Body weights were recorded at acclimatization start, on test day 1 (prior to administration), on test days 8 and 15. All animals were necropsied and macroscopically examined.
Results
No intercurrent deaths occurred during the course of the study. After treatment on test day 1, 2 of 5 animals showed ruffled fur at all observation time points. From test day 2 onwards, no clinical signs were observed in any animal. The body weight of the animals was within the range commonly recorded for this strain and age. No abnormal macroscopic findings were recorded at necropsy.
Conclusion
The median lethal dose of the test substance after single oral administration to female rats, observed over a period of 14 days, is: LD50(female rat): greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Klimisch grade 1, modern GLP compliant study.
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:
- 12 November 2013 to 03 December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised guideline
- Justification for type of information:
- With regard to why some higher tier testing was conducted and included in this dossier without prior to submission of a testing proposal to EU: global chemical companies who manufacture and/or place substances on the global market are obligated to meet the relevant chemical control laws in each jurisdiction that they do business. For this EC number 941-129-0, additional testing was required in order to meet global registration requirements outside of the EU. The requirements of Article 22 of REACH place a responsibility on the registrant to update their registration with relevant new information. These additional studies required for non-EU global registration purposes were deemed as relevant information and hence they were included in the EU REACH dossier.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: RccHan WIST(SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, B.V. Horst, Netherlands
- Age at study initiation: 8 to 12 Weeks
- Weight at study initiation: Males 242.6 to 281.7g, Females 208.79 to 210.74g
- Fasting period before study: None
- Housing: Makrolon Type 3 cages furnished with woodflakes.
- Diet (e.g. ad libitum): Teklad Rat-Mouse Rodent Diet. ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): >30 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light/dark cycle
IN-LIFE DATES: 12 November 2013 to 03 December 2013 - Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: ca. 10%
- Type of wrap if used: self adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water, dried with paper towels.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 500 mg/ml, 4 ml/kg body weight
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- Single dose level of 2000 mg/kg bodywight
- No. of animals per sex per dose:
- 5m, 5f, dosed at 2000 mg/kg bw
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity ½, 1, 2, 3 and 5 hours after dosing and subsequently twice daily for 15 days. Animals were weighed on days 1, 8 and 15
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, dermal reaction - Statistics:
- No statistical analysis was performed.
- Preliminary study:
- not applicable.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No intercurrent deaths occured during the course of the study.
- Clinical signs:
- other: Scratching was observed on the back of one female (animal No. 7) during the first two days after removal of dressing.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of the test substance after single dermal application to rats of both sexes, observed over a period of 14 days, is greater than 2000 mg/kg body weight.
- Executive summary:
Test Guidance
OECD Guideline 404 and EC Method B3
Method and materials
Five male and five female RccHan:WIST (SPF) rats were treated with the test substance at the limit dose of 2000 mg/kg by dermal application. The test item was formulated in PEG 300 at a concentration of 0.5 g/mL and administered at a dose volume of 4 mL/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability, clinical signs and local dermal signs were recorded. All animals were examined for clinical signs before treatment, within the first 30 minutesand approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2 - 15. Local dermal signs were noted once daily from test day 2 to 15. Mortality/viability was recorded before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during test days 2 - 15. Body weights were recorded on test day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and macroscopically examined.
Results
No intercurrent deaths occurred during the course of the study. Scratching was observed on the back of one female during the first two days after removal of dressing. No local dermal signs were observed throughout the entire observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
Conclusion
The median lethal dose of the test substance after single dermal application to rats of both sexes, observed over a period of 14 days, is: LD50 (rat) greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Klimisch grade 1, modern GLP compliant study.
Additional information
Oral
The acute toxicity of the test item when administered by a single oral gavage to rats was investigated according to OECD test guideline No. 420 and Commission Regulation (EC) No. 440/2008, B.1. To determine the dose level for the main study, one sighting study was conducted with one female RccHan:WIST (SPF) rat. The animal was treated with the test item at a dose level of 2000 mg/kg body weight by single oralgavage administration. The test item was formulated in Polyethylene glycol 300 (PEG 300) at a concentration of 0.2 g/mLand administered at a dosing volume of 10 mL/kg body weight. Since no mortality occurred in the animal dosed at 2000 mg/kg, four additional females were treated at this dose level in the main study. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2 - 15. Mortality/viability was recorded before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during testdays 2 - 15. Body weights were recorded at acclimatization start, on test day 1 (prior to administration), on test days 8 and 15. All animals were necropsied and macroscopically examined.
No intercurrent deaths occurred during the course of the study. After treatment on test day 1, 2 of 5 animals showed ruffled fur at all observation time points. From test day 2 onwards, no clinical signs were observed in any animal. The body weight of the animals was within the range commonly recorded for this strain and age. No abnormal macroscopic findings were recorded at necropsy.
The median lethal dose of the test item after single oral administration to female rats, observed over a period of 14 days, is: LD50(female rat): greater than 2000 mg/kg body weight.
Dermal
In accordance with OECD Guideline 404 and EC Method B3, five male and five female RccHan:WIST (SPF) rats were treated with test item at the limit dose of 2000 mg/kg by dermal application. The test item was formulated in PEG 300 at a concentration of 0.5 g/mL and administered at a dose volume of 4 mL/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability, clinical signs and local dermal signs were recorded. All animals were examined for clinical signs before treatment, within the first 30 minutesand approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2 - 15. Local dermal signs were noted once daily from test day 2 to 15. Mortality/viability was recorded before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during test days 2 - 15. Body weights were recorded on test day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and macroscopically examined.
No intercurrent deaths occurred during the course of the study. Scratching was observed on the back of one female during the first two days after removal of dressing. No local dermal signs were observed throughout the entire observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.
The median lethal dose of the test item after single dermal application to rats of both sexes, observed over a period of 14 days, is: LD50 (rat): greater than 2000 mg/kg body weight.
Inhalation
The substance is a liquid with a vapour pressure of 0.000028 Pa at 25°C and is used primarily as a component of lubricants and greases by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route.
Justification for selection of acute toxicity – oral endpoint
One study is available. Guideline, GLP study; K=1
Justification for selection of acute toxicity – dermal endpoint
One study is available. Guideline, GLP study; K=1
Justification for classification or non-classification
In an acute oral toxicity study in rats the LD50 was determined to be > 2000 mg/kg bw.
In an acute dermal study in rats the LD50 was determined to be > 2000 mg/kg bw.
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute toxicity
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