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EC number: 938-645-3 | CAS number: 1689515-39-6
- 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
Two acute oral toxicity studies are available with the substance, conducted equivalent to OECD 401. The LD50 in mice was determined to be >5939 mg/kg and the LD50 in rats was determined to be approx. 7935 mg/kg. The lowest value is selected as the key value for the CSA.
An acute dermal toxicity study conducted with a substance analogue in accordance with OECD 402 and according to GLP principles was considered appropriate to determine the acute dermal toxicity of the substance. The acute dermal toxicity was determined to be >2612 mg/kg in a limit test.
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:
- June 25, 1980 - August 4, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study meets the EC Standards (conducted equivalent to OECD 401). Deviations: lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: ca. 20 gram
No further details available - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data available
- Doses:
- 10, 15 and 20 mL/kg (aqueous solution)
- No. of animals per sex per dose:
- 10 animals per dose (sex unknown)
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 5 days
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 15 - < 20 mL/kg bw
- Based on:
- test mat.
- Remarks:
- (aqueous solution)
- Remarks on result:
- other: Aqueous solution with a solid content of approximately 37%
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 16 050 - < 21 400 mg/kg bw
- Based on:
- test mat.
- Remarks:
- (aqueous solution)
- Remarks on result:
- other: Aqueous solution with a solid content of approximately 37%
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 939 - < 7 918 mg/kg bw
- Based on:
- other: expressed as solid content
- Remarks on result:
- other: Results expressed for the substance
- Mortality:
- - No mortalities occurred in the group administered 10 ml/kg.
- One and all ten animals died in the group of mice receiving 15 and 20 ml/kg bw, respectively - Clinical signs:
- other: no data
- Gross pathology:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study conducted equivalent to OECD 401, the LD50 was determined to be between 15 and 20 mL/kg (aqueous solution), which can be converted to between 16,050 and 21,400 mg/kg (for the aqueous solution). This corresponds to a LD50 between 5,939 and 7,918 mg/kg for the substance.
Reference
RESULTS
Group |
Dose (mL/kg b.w.) |
Mortality |
Group mortality (%) |
1 |
10.0 |
0/10 |
0 |
2 |
15.0 |
1/10 |
10 |
3 |
20.0 |
10/10 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 939 mg/kg bw
- Quality of whole database:
- The study has Klimisch score 2
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 236 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 612 mg/kg bw
- Based on:
- other: expressed as solid content
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: expressed as surfactant content
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 dermal ( rat): > 2612 mg/kg bw (expressed as solid content). This result is read across to the registered substance.
- Executive summary:
An acute dermal toxicity study (limit test) was conducted with a related member of the chemical category (C8-C18 alkyl derivativies) in accordance with OECD 402 and according to GLP principles. A total of 10 rats (5 males and 5 females) were occlusive exposed to 4.47 mL/kg of an aqueous solution of the substance for 24 hours. The dose level was based on the surfactant content of the substance. One female was found dead on day 2. The majority of surviving animals showed chromodacryorrhoea, laboured respiration, rales, gasping, salivation, piloerection and hypothermia between days 1 and 2. No abnormalities were found at macroscopic post mortem examination of the surviving animals. Beginning autolysis was observed for the female that was found dead on day 2. Based on the results of this study the substance does not need to be classified for acute dermal toxicity in accordance with the CLP Regulation as the acute dermal toxicity of the substance was determined to be above 2612 mg/kg.
The results are read across to the registered substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 612 mg/kg bw
- Quality of whole database:
- The study (performed with substance analogue) has Klimisch score 1
Additional information
Acute toxicity: oral
There are two studies available, both performed similar to OECD 401. In both studies, the substance was studied as an aqueous solution. In an acute oral toxicity study in mice, the LD50 was determined to be between 15 and 20 mL/kg (aqueous solution), which corresponds to a LD50 in mice between 5939 and 7918 mg/kg for the substance. In an acute oral toxicity study in rats, the LD50 was determined to be 14.56 mL/kg (aqueous solution), which corresponds to a LD50 of approx. 7935 mg/kg for the substance. The lowest obtained dose descriptor (>5939 mg/kg) is selected as the key value for the chemical safety assessment.
Acute toxicity: dermal
An acute dermal toxicity study (limit test) was conducted with a substance analogue (C8-C18 alkyl derivatives) in accordance with OECD 402 and according to GLP principles. A total of 10 rats (5 males and 5 females) were occlusive exposed to 4.47 mL/kg of an aqueous solution of the substance for 24 hours. The dose level was based on the surfactant content of the substance. One female was found dead on day 2.The majority of surviving animals showed chromodacryorrhoea, laboured respiration, rales, gasping, salivation, piloerection and hypothermia between days 1 and 2. No abnormalities were found at macroscopic post mortem examination of the surviving animals. Beginning autolysis was observed for the female that was found dead on day 2. Based on the results of this study the acute dermal toxicity of the substance was determined to be above 2612 mg/kg.
The rationale to read across the data is attached in Section 13.
Justification for classification or non-classification
In accordance with the CLP Regulation the substance is not classified for acute toxicity as the LD50 oral in mice (and rats) was determined to be >5939 mg/kg and as the LD50 dermal in rats was determined to be >2612 mg/kg.
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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