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EC number: 944-399-8 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- See attached read-across justification
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: Contact laboratory protocol
- GLP compliance:
- no
- Specific details on test material used for the study:
- OTHER SPECIFICS: Tradename Alfol 14
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2,3 kg - 2,9 kg - Type of coverage:
- other: occlusive (intact and abraded)
- Vehicle:
- other: 1% w/w gum tragacanth
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the dose was applied to the trunk of the animals under occlusion.
- Type of wrap if used: plastic binder
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material was washed away and the area dried with absorbent paper towels.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): maximum dose 3-4 mL/kg
- Concentration (if solution): 50% in 1% w/w gum tragacanth
VEHICLE
- Concentration (if solution):1% - Duration of exposure:
- 24 h
- Doses:
- 2000, 4000 and 8000 mg/kg
- No. of animals per sex per dose:
- 2 (1M+1F each intact and abraded)
- Control animals:
- no
- Details on study design:
- - Time after start of exposure: 24 h
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs of systemic toxicity and skin reactions at application site were recorded on the day of dosing and throughout the 14 day observation period.
. Body weights were recorded prior to dosing and on observation day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: skin reactions at application site - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 8 000 mg/kg bw
- Mortality:
- On observation days 9 and 11.
Number of deaths at each dose: abraded 0/2, 0/2 and 2/2; intact 0/2, 0/2, 0/2. - Clinical signs:
- other: At 8000 mg/kg, two surviving animals showed signs of weakness, emaciation and pallor. All returned to normal within 4 days of exposure. At 24 hours after administration all animals showed slight to moderate erythema, desquamation, wrinkling and dryness. I
- Gross pathology:
- Animals which succumbed showed depleted visceral fatty tissue (1 rabbit), moderate dermal irritation, and desquamation at the treatment site (2 rabbits). One animal, which was sacrificed, showed a slight accumulation of clear, viscous fluid within the peritoneal cavity and crazing over the kidney cortex. In all other animals the necropsy findings were unremarkable.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The rabbit dermal LD50 after 24 h occlusive exposure for Alfol 14 was approximately 8000 mg/kg.
All survivors showed skin irritation at the application site throughout the observation period. Signs of intoxication included weakness, emaciation and pallor. - Executive summary:
The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Alfol 14) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 2 studies.
The study according to contract laboratory protocol, reported by Scientific Associates Inc. (1977b) in New Zealand White rabbits is reported here.
The test material Alfol 14, diluted 50% in a 1% w/w gum tragacanth was applied to the trunk of male and female rabbits for 24 h occlusive exposure at doses of 2000, 4000 and 8000 mg/kg bw. Each dose group consisted of 4 animals: 1 male and 1 female each with intact and abraded skin.
Mortality, clinical signs of systemic toxicity and skin reactions at the application site were recorded on the day of dosing and throughout the 14 day observation period. Body weights were recorded prior to dosing and on observation day 14. All decedents and survivors were subject to gross necropsy.
Mortality was observed on observation days 9 and 11.The number of deaths at each dose were: abraded 0/2, 0/2 and 2/2; intact 0/2, 0/2, 0/2.
At 24 hours after administration all animals showed slight to moderate erythema, desquamation, wrinkling and dryness. In all surviving animals desquamation and wrinkling persisted to the end of the observation period.
At 8000 mg/kg, two surviving animals showed signs of weakness, emaciation and pallor. All returned to normal within 4 days of exposure. Body weights of surviving animals showed a slight loss in 1 animal, constant weight in 1 animal and gains within expected limits in 8 animals.
Animals which succumbed showed depleted visceral fatty tissue (1 rabbit), moderate dermal irritation, and desquamation at the treatment site (2 rabbits). One animal, which was sacrificed, showed a slight accumulation of clear, viscous fluid within the peritoneal cavity and crazing over the kidney cortex. In all other animals the necropsy findings were unremarkable.
The rabbit dermal LD50 for Alfol 14 (24 hours occluded) was approximately 8000 mg/kg bw.
(Reference: Scientific Associates, Inc. 1977b Hayes Consultancy Service Bromley, Kent).
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: Smyth et al, 1962
- GLP compliance:
- no
- Specific details on test material used for the study:
- OTHER SPECIFICS: Test substance: tetradecanol (mixed isomers)
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 -3.5 kg - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: entire trunk
- Duration of exposure:
- Not reported
- Doses:
- Not reported
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 7.13 mL/kg bw
- 95% CL:
- 4.41 - 11.52
- Remarks on result:
- other: Equivalent to 5847 mg/kg using the density of 0.82 g/cm3.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 was 7.13 mL/kg (confidence limits 4.41-11.52 mL/kg)., equivalent to 5847 mg/kg using the density of 0.82 g/cm3. Results were not reported in detail.
- Executive summary:
The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, tetradecanol (mixed isomers)) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 2 acute dermal toxicity studies.
The study according to the method of Smyth et al, 1962 , reported by Smith et al. (1969) in New Zealand White rabbits is reported here.
Tetradecanol (mixed isomers) was applied on the entire trunk of male New Zealand White rabbits under occlusion.
The rabbit dermal LD50 for tetradecanol (mixed isomers) was 7.13 mL/kg (confidence limits 4.41-11.52 mL/kg), equivalent to 5847 mg/kg using the density of 0.82 g/cm3.
(Reference: Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C., Striegel, J.A., and Nycum, J.S. 1969. Range-finding toxicity data: List VII. Am. Ind. Hyg. Assoc. J. 30(5):470-476).
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1962
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: Smyth et al, 1962
- GLP compliance:
- no
- Specific details on test material used for the study:
- OTHER SPECIFICS: Test substance: icosanol (mixed isomers)
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 -3.5 kg - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: entire trunk
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Remarks on result:
- other: >16800 mg/kg using the density of 0.84 g/cm3.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 was >20 mL/kg (>16800 mg/kg using the density of 0.84 g/cm3). Results were not reported in detail.
- Executive summary:
The IUCLID dataset of 1 -Eicosanol (CAS 629 -96 -9, icosanol (mixed isomers)) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes one Klimisch 2 study according to the method of Smyth et al., 1962 in New Zealand White rabbits.
Undiluted icosanol (mixed isomers) was applied on the entire trunk of male rabbits under occlusion. Clinical signs were recorded during a 14 day observation period.
The rabbit dermal LD50 for icosanol (mixed isomers) was >20 mL/kg (>16800 mg/kg using the density of 0.84 g/cm3).
(Reference: Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C.,Striegel, J.A., and Nycum, J.S. 1969. Range-finding toxicity data: List VII. Hyg. Assoc. J.30(5):470-476.)
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: not specified
- Principles of method if other than guideline:
- 10 male rabbits/group were treated with a slurry of 33% aqueous C12 ASO4 Na at 150, 300, 600, 1200 or 2000 mg/kg bw for 24 hours to both intact and abraded skin.
- GLP compliance:
- no
- Specific details on test material used for the study:
- OTHER SPECIFICS: 33 % slurry of the TS
- Species:
- rabbit
- Sex:
- male
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
both to intact and abraded skin - Duration of exposure:
- 24 h
- Doses:
- single dosing with 150, 300, 600, 1200 or 2000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 200 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 150 mg/kg bw: 1/10
300 mg/kg bw: 2/10
600 mg/kg bw: 4/10
1200 mg/kg bw: 8/10
2000 mg/kg bw: 10/10 - Clinical signs:
- other: tremors, tonic-clonic convulsions, respiratory failure; terminal skin appearance: slight scaling to leathery
- Gross pathology:
- not further specified
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- The LD50 was about 200 mg/kg bw, based on active ingredient.
- Executive summary:
The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 2 study.
The acute dermal toxicity of Sodium dodecyl sulfate (CAS 151-21-3) was evaluated in male rabbits. Sodium dodecyl sulfate was applied as a 33% slurry in water at doses of 150, 300, 600, 1200 or 2000 mg/kg bw both to intact and abraded skin over 24 hrs. Clinical signs and mortality and body weights were observed during 14 days. Necropsy was performed on all animals (death and surviving) and gross pathological changes were noted.
Mortality was observed in 1/10, 2/10, 4/10, 8/10 and 10/10 animals at doses of 150, 300, 600, 1200 and 2000 mg/kg bw respectively.
The observed clinical signs include: tremors, tonic-clonic convulsions, respiratory failure, decrease in body weights (300 or 600 mg/kg bw). The terminal skin appearance was slight scaling to leathery. Necropsy data were not specified.
The male dermal LD50 of Sodium dodecyl sulfate was ca. 200 mg/kg bw based on active substance.
Reference: Carson S & Oser BL (1964) Dermal toxicity of sodium lauryl sulfate. J Soc Cosmet Chem 15, 137 – 147.
Mortalities were 1/10, 2/10, 4/10, 8/10 and 10/10 animals in the 150, 300, 600, 1200 or 2000 mg/kg bw groups, respectively. Clinical signs included tremors, tonic-clonic convulsions, and respiratory failure. A decrease in body weights was seen during the 14 day post-dose observation period in animals dosed with 300 or 600 mg/kg bw. At necropsy, the treated skin area appeared leathery and showed slight scaling. The LD50 was about 200 mg/kg bw, based on active ingredient.
Data source
Materials and methods
Test material
- Reference substance name:
- Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols
- EC Number:
- 944-399-8
- Cas Number:
- not yet assigned
- Molecular formula:
- see information in structural formula
- IUPAC Name:
- Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols
Constituent 1
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008), based on worst case LD50 values
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- When the LD50 of the target substance was calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008), based on worst case LD50 values, this resulted in a dermal LD50 of 2373 mg/kg bw in rats. It can therefore be concluded that the oral LD50 of the registered substance is >2000 mg/kg bw. No classification is warranted.
- Executive summary:
When the LD50 of the target substance was calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008), based on worst case LD50 values, this resulted in a dermal LD50 of 2373 mg/kg bw in rats. It can therefore be concluded that the oral LD50 of the registered substance is >2000 mg/kg bw. No classification is warranted.
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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