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EC number: 952-655-5 | CAS number: -
- 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 LD50 of the available acute oral and dermal toxicity studies performed with a consitiuent of the registration substance or strucutral analogues, were derived at greater than 2000 mg/kg bw.
-Acute oral toxicity:
tetradecyl myrisitate (CAS No 3234 -85 -3): LD50 > 5000 mg/kg bw
isooctadecal palmitate (CAS No 72576 -80 -8): LD50 > 2000 mg/kg bw
-Acute dermal toxicity:
decyl octadec-9 -enoate (CAS No 3687 -46 -5): LD50 > 2000 mg/kg bw
2 -octyldodecyl isooctadecanoate (CAS No 93803 -87 -3): 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:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- the analytical purity of the test substance is not reported
- GLP compliance:
- no
- 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
- Weight at study initiation: 176-296 g
- Fasting period before study: overnight
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg - Doses:
- 5000 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: observations of mortality and signs of toxicity were made 1, 3, 4, 6 and 24 h after administration and daily thereafter; animals were weighed prior to dosing and prior to necropsy.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One male rat died on day 4 after administration. No information on the cause of death was provided.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- No substance-related findings were noted during the necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 5000 mg/kg bw
- Executive summary:
The acute oral LD50 of tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance, in rats of both sexes observed over a period of 14 days is > 5000 mg/kg bw.
Based on the result of this study the substance not subject for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliable with restrictions
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
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:
- weight of evidence
- Study period:
- 19 May - 2 Jun 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2
4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2 - Reason / purpose for cross-reference:
- read-across source
- 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 (see Table 1).
- Clinical signs:
- other: Piloerection was observed from 4 h - day 2 after dosing in 2/5 males (see Table 2). Chromodacryorrhoea (excessive secretion of a reddish-brown liquid from the eyes) (grade 1) was observed in 3/5 males 2-4 hours after dosing. No systemic clinical signs of
- Gross pathology:
- The necropsy and histopathological examination did not reveal substance-related findings.
- Other findings:
- - Other observations: On the treated skin area, erythema was observed for up to 4 days during Day 3-7 in 3/5 females. Scales or scabs (grade 1) were noted on the treated skin area in 5/5 females and 3/5 males for up to 9 days during Day 7-15 of the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (dermal) of the substance is greater than 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of decyl octadec-9 -enoate (CAS No 3687-46-5), a strucutral analogue, was assessed in a study according to OECD Guideline 402 with rats. As a result of the study, the LD50 (dermal) was determined to be > 2000 mg/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 12 - 26 Feb 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2
4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2 - Reason / purpose for cross-reference:
- read-across source
- 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 (see Table 1).
- Clinical signs:
- other: Red staining of the neck fur (score 1 of 3) was observed in 1/5 females on Day 8-13. This is an effect that is frequently seen in rats under stressful conditions and is therefore not considered to be toxicologically relevant. No other clinical signs were
- Gross pathology:
- The necropsy and histopathological examination did not reveal any substance-related findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of 2-octyldodecyl isooctadecanoate, a structural analogue, in rats of both sexes observed over a period of 14 days is > 2000 mg/kg bw.
- Executive summary:
The acute dermal LD50 of 2-octyldodecyl isooctadecanoate (CAS No 93803 -87 -3), a structural analogue, in rats of both sexes observed over a period of 14 days (according to OECD 402) is > 2000 mg/kg bw.
Based on the result of this study the substance is not subject for labelling and classification requirements according to regulatory requirements.
Referenceopen allclose all
Table 1: Mortality and clinical signs
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
2000 |
0/3/5 |
4 h – day 2 |
Day 1-3 |
0 |
Females |
||||
2000 |
0/0/5 |
- |
Day 1 |
0 |
LD50 > 2000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with systemic clinical signs
third number = number of animals used Table 2: Clinical signs, systemic/local
Effect* |
Max grade |
Male No./duration (hours or day after dosing) |
Female No./duration (hours or day after dosing) |
||||||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
Systemic |
|
|
|
|
|
|
|
|
|
|
|
Piloerection |
1 |
4 h - 2 d |
|
|
|
4 h - 2 d |
|
|
|
|
|
Chromoda-cryorrhoea |
3 |
|
2 - 4 h |
2 - 4 h |
4 h |
|
|
|
|
|
|
Local |
|
|
|
|
|
|
|
|
|
|
|
Erythema, focal |
4 |
|
|
|
|
|
7 d |
|
7 d |
3 – 7 d |
7 d |
Scales |
3 |
|
|
8 – 10 d |
7 – 15 d |
|
7 – 8 d, 14 d |
8 – 11 d |
7 – 9 d |
7 – 8 d |
7 – 9 d |
Scabs |
3 |
|
7 - 11 d |
|
9 - 15 d |
|
8 – 13 d |
|
|
|
|
* all grade 1
Table 1: mortality and clinical signs
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
2000 |
0/0/5 |
- |
- |
0 |
Females |
||||
2000 |
0/1/5 |
Day 8-13 |
- |
0 |
Overall LD50 > 2000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with systemic 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:
- Reliable with restrictions
Additional information
Justification for classification or non-classification
Based on the results obtained the submission substance has not to be classified for acute toxic effects according to Regulation (EC) No. 1272/2008 (CLP).
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.