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EC number: 615-247-5 | CAS number: 71060-57-6
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Reproductive / developmental screening test (oral, rat): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day, NOAEL (reproductive toxicity) ≥ 1000 mg/kg bw/day
Read-across based on grouping of substances (category approach) considering all available data on reproductive / developmental toxicity on screening level in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category.
An extended one-generation reproductive toxicity study (EOGRTS, OECD 443) is not required for alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) as the requirements given in Annex IX, Section 8.7.3, Column 1, of the REACH Regulation (EC) No. 1907/2006 are not met.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the category justification provided in the category object.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxicologically relevant effects observed
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxicologically relevant effects observed
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Applying read-across based on grouping of substances (category approach), no toxicologically relevant effects in relation to reproductive / developmental toxicity and a NOAEL for reproductive toxicity ≥ 1000 mg/kg bw/day are predicted for the target substance.
- Executive summary:
The available data on reproductive / developmental toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category indicate no toxicologically relevant effects for the target substance. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the AE category are unlikely to lead to differences with respect to reproductive / developmental toxicity.
Reference
For a detailed assessment of the reproductive / developmental toxicity of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available information comprises adequate and reliable (Klimisch score 1) studies from various source substances in the Alcohol Ethoxylates (AE) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The data pool of the AE category is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, Section 8.7, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive / developmental toxicity screening
No data on reproductive toxicity on screening level of alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) are available. In order to assess reproductive toxicity, studies in the data pool of the Alcohol Ethoxylates (AE) category are considered in a read-across approach. Due to differences in systemic toxicity between AE substances containing only linear constituents and those containing linear and branched constituents, as observed in studies with repeated dose administration, only data obtained with AE substances in the 'linear' subgroup of the category are used to read-across systemic endpoints, incl. reproductive toxicity, to AE substances containing only linear constituents. Adequate and reliable studies are available for the following linear AE members:
- Alcohols, C10, ethoxylated, < 2.5 EO (CAS No. 26183-52-8, EC No. 500-046-6): (OECD 422) NOAEL (reproductive toxicity) ≥ 1000 mg/kg bw/day
- Alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3): (OECD 422) NOAEL (reproductive toxicity) ≥ 1000 mg/kg bw/day
- Hexadecan-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-95-9, EC No. 500-014-1): (OECD 422) NOAEL (reproductive toxicity) ≥ 1000 mg/kg bw/day
- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): (OECD 422) NOAEL (reproductive toxicity) ≥ 1000 mg/kg bw/day
- (Z)-9-Octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2): (OECD 422) NOAEL (reproductive toxicity) ≥ 1000 mg/kg bw/day
Conclusion
All available study results indicate a lack of reproductive toxicity, thus demonstrating the similarity of the linear AE substances with respect to toxicological properties. Treatment did not cause any toxicologically relevant changes in relation to mating and fertility indices, precoital time, number of implantation sites, gestation index and duration, parturition and maternal care. Sporadically occurring irregular cycles, variations in precoital time and the number of not pregnant females were not considered treatment-related due to their incidental nature and/or absence of a dose relationship. Therefore, a NOAEL ≥ 1000 mg/kg bw/day for reproductive toxicity is used for the hazard assessment and classification and labelling of the linear AE substances, incl. alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5). For a detailed assessment of the reproductive and developmental toxicity of the linear member substances of the AE category, please refer to the category justification documentation attached to the category object.
Extended one-generation reproductive toxicity study
According to Annex IX, Section 8.7.3, Column 1, of the REACH Regulation (EC) No. 1907/2006 an extended one-generation reproductive toxicity study (EOGRTS, OECD 443) must be performed if the available repeated dose toxicity studies (e.g. 28-day or 90-day studies, OECD 421 or 422 screening studies) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation to reproductive toxicity. The repeated dose toxicity as well as reproductive / developmental data available for various members of the AE category do not provide any concern in relation to reproductive toxicity. No toxicologically relevant effects were noted in reproductive organs and tissues. Please refer to the category justification attached to the category object for details on studies and the grouping and read-across approach in the AE category.
It is, therefore, concluded that the requirements given in Annex IX, Section 8.7.3, Column 1, of the REACH Regulation are not met and an EOGRTS is not required for alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5). However, pursuant to compliance check final decision for a number of substances in the AE category, several subchronic (OECD 408) and prenatal developmental toxicity studies (OECD 414, in first and/or second species) are currently ongoing. The evaluation whether an EOGRTS study is required will be reassessed once all experimental results will be available.
Effects on developmental toxicity
Description of key information
Reproductive / developmental screening test (oral, rat): NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/day, not teratogenic
Read-across based on grouping of substances (category approach) considering all available data on reproductive / developmental toxicity on screening level in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category.
Developmental toxicity (oral, rat): NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/day, not teratogenic
Read-across based on grouping of substances (category approach) considering all available data on combined subacute repeated dose toxicity studies with the reproductive / developmental toxicity screening test (OECD 422) conducted with members of the 'linear' subgroup of the AE category.
Pursuant to compliance check final decision for a number of substances in the AE category, several prenatal developmental toxicity studies according to OECD guideline 414 are currently ongoing. The NOAEL for developmental toxicity will be re-evaluated once the results of the OECD 414 studies are available.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the category justification provided in the category object.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no toxicologically relevant effects observed
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no toxicologically relevant effects observed
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Applying read-across based on grouping of substances (category approach), no toxicologically relevant effects in relation to developmental toxicity / teratogenicity and a NOAEL for developmental toxicity ≥ 1000 mg/kg bw/day are predicted for the target substance.
are predicted for the registered substance. - Executive summary:
The available data on developmental toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category indicates no toxicologically relevant effects for the target substance. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the AE category are unlikely to lead to differences with respect to developmental toxicity.
Reference
For a detailed assessment of the developmental toxicity of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available information comprises adequate and reliable (Klimisch score 1) studies from various source substances in the Alcohol Ethoxylates (AE) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The data pool of the AE category is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, Section 8.7, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive / developmental toxicity screening
No data on developmental toxicity of alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) are available. In order to assess developmental toxicity, studies in the data pool of the Alcohol Ethoxylates (AE) category are considered in a read-across approach. Due to differences in systemic toxicity between AE substances containing only linear constituents and those containing linear and branched constituents, as observed in studies with repeated dose administration, only data obtained with AE substances in the 'linear' subgroup of the category are used to read-across systemic endpoints, incl. developmental toxicity, to AE substances containing only linear constituents. Adequate and reliable studies investigating developmental toxicity on screening level are available for the following linear AE members:
- Alcohols, C10, ethoxylated, < 2.5 EO (CAS No. 26183-52-8, EC No. 500-046-6): (OECD 422) NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/day, not teratogenic
- Alcohols, C12-14, ethoxylated, < 2.5 EO (CAS No. 68439-50-9, EC No. 500-213-3): (OECD 422) NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/day, not teratogenic
- Hexadecan-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-95-9, EC No. 500-014-1): (OECD 422) NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/day, not teratogenic
- Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5): (OECD 422) NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/day, not teratogenic
- (Z)-9-Octadecen-1-ol, ethoxylated, < 2.5 EO (CAS No. 9004-98-2, EC No. 500-016-2): (OECD 422) NOAEL (developmental toxicity) ≥ 1000 mg/kg bw/day, not teratogenic
Conclusion
All available study results indicate a lack of developmental toxicity and the absence of any teratogenic effect, thus demonstrating the similarity of the linear AE substances with respect to in utero and early-life development. Treatment did not cause any toxicologically relevant changes in relation to sex ratio and early postnatal pup development, i.e. mortality, clinical signs, body weights, sex, anogenital distance, areola/nipple retention and macroscopy, measurement of thyroid hormone T4 (post-natal day (PND) 14-16). Sporadically pups were found dead at first litter check or pups were missing on PND 4. These incidences were not considered of toxicological relevance since the mortality incidence did not show dose-related trends. Moreover, variations and retardations observed remained within the range considered normal for pups of this age in all studies. Therefore, a NOAEL ≥ 1000 mg/kg bw/day for developmental toxicity and a lack of any teratogenic effect are considered for the hazard assessment and classification and labelling of the linear AE substances, incl. alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5). For a detailed assessment of the reproductive and developmental toxicity of the linear member substances of the AE category, please refer to the category justification attached to the category object.
Prenatal developmental toxicity in a first species
No data on prenatal developmental toxicity of alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) are available. In order to assess this endpoint, studies in the data pool of the AE category will be considered. Pursuant to final compliance check decision for a number of linear AE substances, several prenatal developmental toxicity studies according to OECD guideline 414 are currently ongoing. Until results of these studies will be available, a NOAEL of ≥ 1000 mg/kg bw/day for developmental toxicity as determined in the reproductive / developmental toxicity screening tests with the linear AE substances listed above is considered as the NOAEL for prenatal development for the hazard assessment and the evaluation of classification and labelling of the linear AE substances. The NOAEL for developmental toxicity established for the linear AE substances will be re-evaluated once the results of the OECD 414 studies are available. For a detailed assessment of the developmental toxicity of the AE category, please refer to the category justification attached to the category object.
Justification for classification or non-classification
The available data on reproductive and developmental toxicity obtained with members of the 'linear' subgroup of the Alcohol Ethoxylates (AE) category do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. Based on grouping of substances (category approach), alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) is predicted not to fulfil the classification criteria and is consequently not classified for reproductive and developmental toxicity.
Additional information
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.