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EC number: 614-682-8 | CAS number: 68647-95-0
- 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
rat, oral: LD50 > 2000mg/kg b.w. (BASF SE 2012, GLP, OECD423)
rat, dermal: LD50 > 5000mg/kg b.w. (BASF SE 2012, GLP, OECD 402)
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted Dec. 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adoopted Dec. 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: app. 10 weeks
- Weight at study initiation: 175.7 - 203.7g
- Fasting period before study: 16h, water available ad lib.
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P) ad libitum; SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 10
- Photoperiod (hrs dark / hrs light): 12h/12h - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.22mL/kg b.w.
DOSAGE PREPARATION (if unusual): the test item was heated at 70°C for app. 1h for better handling, and administered luke warm - Doses:
- 2000
- No. of animals per sex per dose:
- 6 (in two experiments with 3 animals each)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, at least once daily on workdays thereafter
- Frequency of weighing: shortly before administration, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality occured
- Mortality:
- No mortality occured
- Clinical signs:
- other: In the first experiment, impaired general state and dyspnoe occured in all animals for up to 4h during the first day. Salivation right after application and piloerection (2h - 4h after application) was observed in two animals. The second test group showed
- Gross pathology:
- No abnormalities observed.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted Feb. 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- adopted August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- 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: Charles River Wega GmbH, Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females: app. 12 weeks
- Weight at study initiation: on average 229.8g (males), 213.0g (females)
- Fasting period before study: no
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P) ad lib., SDS Special Diets Services, Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 10
- Photoperiod (hrs dark / hrs light): 12h/12h - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: app. 40cm² (= at least 10% of body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing with warm water
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.55mL/kg b.w.
- For better handling the test item was heated at 60°C for approx. 1 hour. The test item was administered lukewarm. - Duration of exposure:
- 24h
- Doses:
- 5000mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, at least once daily on workdays thereafter
- Frequency of weighing: shortly before administration, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, scoring of skin findings according to Draize (30-60min after removal of the dressing and several times until the end of the study) - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality occured
- Clinical signs:
- other: No systemic toxicity was observed in males or females. Well-defined erythema (grade 2) and very slight edema (grade 1) were noted in all male animals from study day 1 until study day 3 after application. Furthermore scaling was observed in 3 male animals
- Gross pathology:
- No abnormalities detected.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Reference
Tabel 1
Nature and duration of local clinical signs(males) | |||||
Animal No.: | R 902 | R 903 | R 904 | R 905 | R 906 |
Erythema grade 2: | d1 - d3 | d1 - d3 | d1 - d3 | d1 - d3 | d1 - d3 |
Edema grade 1: | d1 - d3 | d1 - d3 | d1 - d3 | d1 - d3 | d1 - d3 |
Scaling: | d3 - d14 | d3 - d8 | d3 - d14 | d3 - d10 | d3 - d14 |
Incrustations: | d3 - d14 | d7 - d8 | d7 - d14 | d7 - d10 | d8 - d14 |
Table 2
Nature and duration of local clinical signs(females) | |||||
Animal No.: | R 907 | R 908 | R 909 | R 910 | R 911 |
Erythema grade 1: | d6 - d9 | d6 - d9 | d6 - d9 | d6 - d9 | d6 - d8 |
Erythema grade 2: | d1 - d3 | d1 - d3 | d1 - d3 | d2 - d3 | d2 - d3 |
Erythema grade 3: | - | - | - | d1 | d1 |
Scaling: | d3 - d9 | d3 - d9 | d3 - d9 | d3 - d10 | d3 - d10 |
Incrustations: | d7 - d14 | d6 - d14 | d2 - d14 | d2 - d9 | - |
d: day
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Additional information
In an acute oral toxicity study according to OECD423 and GLP (BASF SE 2012), 6 female fasted Wistar rats (3 each in two independent experiments) were given a single oral dose of 2000mg/kg undiluted fatty acids, C18-unsatd., dimers, compds. with coco alkylamines by gavage. The animals were observerd for 14 days and necropsy was performed. No mortality occured. Clinical signs, i.e., bad general state, dyspnoe, salivation, and piloerection, were observed for up to four hours on the first day during the first experiment only. The expected body weight gain had been observed in the course of the study. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Thus the oral LD50 value for this substance is greater than 2000mg/kg b.w.
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of undiluted Fatty acids, C18- unsatd., dimers, compds. with coco alkylamines to the clipped skin
(dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours (BASF SE 2012). No mortality and no systemic toxicity was observed during the for 14 days observation period. The mean body weight of the male animals increased within the normal range throughout the study period. Mean body weight of the female animals stagnated during the first postexposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The following test item-related local effects were recorded during the course of the study:
o Very slight to moderate erythema (grade 1 to 3)
o Very slight edema (grade 1)
o Scaling
o Incrustations
Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 5000 mg/kg b.w. in rats.
In accordance with column 2 of REACH Annex VIII, no acute inhalation toxicity study was conducted as two other routes are provided.
Justification for classification or non-classification
Based on the results of the available studies, fatty acids, C18-unsatd., dimers, compds. with coco alkylamines is not required to be classified for its acute toxicity potential according to 67/548/EEC and CLP/EU-GHS requirements.
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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