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EC number: 939-518-5 | CAS number: 68439-49-6
- 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
Skin irritation / corrosion (in vivo, rabbit, OECD 404): not irritating
Conclusion based on data obtained with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) and considering all available data on skin irritation / corrosion in the Alcohol Ethoxylates (AE) category for substances containing only saturated constituents in a Weight-of-Evidence approach.
Eye irritation (in vivo, rabbit, OECD 405): not irritating
Conclusion based on data obtained with the target substance alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) and considering all available data on eye irritation in the AE category for substances with carbon-chain lengths ≥ C12 in a Weight-of-Evidence approach.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 04 - 18 Nov 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- occlusive dressing, no step-wise testing performed
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: single housing in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen , Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 Nov To: 18 Nov 1986 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approx. 10 cm x 10 cm
- Type of wrap if used: The application site was covered by a gauze bandage and a polyethylene foil (approx. 6 cm x 6 cm). The bandage was fixed with a flexible wrap.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining test substance was gently rinsed with lukewarm water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS: 1, 24, 48, 72 h and 6, 8, 10, 14 days
SCORING SYSTEM: Draize scoring scheme - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- Reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- Reversibility not applicable
- Remarks on result:
- other:
- Remarks:
- No edema formation observed in any animal at any observation time point.
- Irritant / corrosive response data:
- One hour after patch removal, very slight to well defined erythema was observed in all 3 animals. 2/3 animals were without skin reactions at any scoring time point thereafter, whereas very slight erythema (grade 1) was still observed in the third animal 6 days after treatment. On study Days 8 and 10, scabs were noted in this animal. There were no findings on oedema at any reading time point. At termination on study Day 14, all animals were free of skin lesions.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The test substance did not induce skin irritation in an in vivo study according to OECD guideline 404.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the category justification provided in the category object.
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not irritating based on all available skin irritation data in the Alcohol Ethoxylates (AE) category for substances containing only saturated constituents.
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not irritating based on all available skin irritation data in the Alcohol Ethoxylates (AE) category for substances containing only saturated constituents.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Applying read-across based on grouping of substances (category approach), no skin irritating potential is predicted for the target substance.
- Executive summary:
The available data on skin irritation / corrosion in the Alcohol Ethoxylates (AE) category indicate no skin irritation potential 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 in the skin irritation / corrosion potential.
Referenceopen allclose all
Table 1: Erythema scores during the 14 days observation period
Animal | 1 h | 24 h | 48 h | 72 h | 6 days | 8 days | 10 days | 14 days | Mean 24/48/72 h |
1 | 1 | 1 | x1 | x1 | x1 | Sc | Sc | 0 | 1.00 |
2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
x: localised skin reaction; Sc: scabs |
For a detailed assessment of the skin irritation / corrosion potential of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 - 24 Nov 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2020
- Deviations:
- yes
- Remarks:
- No treatment with systemic analgesic or topical anaesthesia of the animals / animal eyes prior, during or after test substance application
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: Individually, in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen (Ssniff Spezialfutter GmbH, Soest, Germany); ad libitum
- Water: Tap water; ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 6 days
Reading time points: 1, 24, 48 and 72 h and 6 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): With lukewarm physiological NaCl solution
- Time after start of exposure: 72 h after application
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- Reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other:
- Remarks:
- Reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other:
- Remarks:
- Reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- Reversibility not applicable
- Irritant / corrosive response data:
- There were no eye irritation reactions observed for any animal during the 6 days observation period.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The test substance did not induce eye irritation in an in vivo study according to OECD guideline 405.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
Data on skin irritation / corrosion are available for alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) as well as several member substances of the Alcohol Ethoxylates (AE) category.
Study with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5)
The skin irritation potential of alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) was investigated according to OECD guideline 404 (Sasol, 1986b). Three albino rabbits (Kleine weiße Russen (Chbb-SPF)) were exposed for 4 h to 0.5 mL of the undiluted test substance under occlusive conditions. Approx. 24 h prior to application, the application sites were clipped. Remaining test substance was gently rinsed with lukewarm water. Skin reactions were observed 1, 24, 48 and 72 h as well as 6, 8, 10 and 14 days after application. One animal showed oedema (score 1) at the 24, 48 and 72 h reading points, which was fully reversible within the 14 days observation period. No further skin reactions (erythema or oedema) were observed in any other animal at any time point. The test substance was therefore evaluated to be not irritating to skin.
Studies in the AE category
Studies on skin irritation / corrosion are available for the following AE substances:
CAS No. |
EC No. |
Substance |
Study protocol |
Hazard conclusion |
27252-75-1 |
500-058-1 |
Octan-1-ol, ethoxylated |
OECD 431 |
Corrosive |
26183-52-8 |
500-046-6 |
Decan-1-ol, ethoxylated |
OECD 404 |
Not irritating |
68439-50-9 |
500-213-3 |
Alcohols, C12-14, ethoxylated |
OECD 404 |
Severely irritating |
68439-49-6 |
939-518-5 |
Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO |
OECD 404 |
Not irritating |
68920-66-1 |
500-236-9 |
Alcohols, C16-18 and C18 unsatd., ethoxylated |
OECD 404 |
Irritating |
OECD 404 |
Not irritating |
|||
9005-00-9 |
500-017-8 |
Octadecan-1-ol, ethoxylated |
Similar OECD 404 |
Not irritating |
66455-14-9 |
500-165-3 |
Alcohols, C12-13, ethoxylated |
Similar OECD 404 |
Not irritating |
160901-19-9 |
500-457-0 |
Alcohols, C12-13, branched and linear, ethoxylated |
OECD 404 |
Not irritating |
106232-83-1 |
500-294-5 |
Alcohols, C12-15, branched and linear, ethoxylated |
Similar OECD 404 |
Not irritating |
Evaluation of skin irritation / corrosion as observed in studies
Most of the available study results for AE substances with a carbon-chain length ≥ C10 containing only fully saturated constituents indicate a generally low irritating potential. Oedema and erythema formation (if any) is slight to moderate and mean oedema and erythema scores are below the threshold for classification according to the criteria of the CLP Regulation (EC) No. 1272/2008. All skin reactions (if any) are fully reversible within the observation period of the respective study. The exception is the findings of the study with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3). The reason for the severely irritating result of the latter study might be the occlusive coverage applied in this study. Exposure to a test material under occlusive conditions is significantly higher than under semi-occlusive conditions which is the standard in the current OECD 404 test guideline. It is reasonable to assume that higher exposures will most likely result in more severe effects. Hence, the results of the study over predict the irritation potential of alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) when assessed against new OECD 404 criteria. Based on all available data on skin irritation / corrosion in the AE category, it is established that the study with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) should be regarded as an outlier most probably related to methodological deviations. The study is not considered in the assessment of the skin irritation potential of the substances in the AE category. Furthermore, the length of the alkyl chain if ≥ C10 does not exert any influence on the skin irritation potential of AE substances. Members of the AE category containing only saturated constituents are generally not irritating to skin, irrespective of their carbon-chain length if it is ≥ C10.
This evaluation is considered sufficiently conclusive for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the skin irritation / corrosion potential of the substances in the AE category, please refer to the category justification attached to the category object.
Eye irritation
Data on eye irritation are available for alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) as well as several member substances of the AE category.
Study with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5)
An in vivo study investigating the eye irritation potential of alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) according to OECD guideline 405 is available (Sasol, 1986c). Three albino rabbits (Kleine weiße Russen (Chbb-SPF)) were treated with 0.1 mL of undiluted test substance for 72 h until the exposed eyes were washed with lukewarm physiological saline. Adverse reactions were scored according to the Draize 1, 24, 48 and 72 h as well as 6 days after application. No reactions were observed in any animal at any time point. Therefore, the study was terminated 6 days after application. Based on the lack of any adverse effects, the test substance is considered not irritating to the eye.
Studies in the AE category
Adequate and reliable studies on eye irritation are available for the following AE members:
CAS No. |
EC No. |
Substance |
Study protocol |
Hazard conclusion |
68439-50-9 |
500-213-3 |
Alcohols, C12-14, ethoxylated |
OECD 405 |
Not irritating |
OECD 405 |
Serious eye damage |
|||
68439-49-6 |
939-518-5 |
Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO |
OECD 405 |
Not irritating |
68920-66-1 |
500-236-9 |
Alcohols, C16-18 and C18 unsatd., ethoxylated |
OECD 405 |
Not irritating |
OECD 405 |
Not irritating |
|||
9005-00-9 |
500-017-8 |
Octadecan-1-ol, ethoxylated |
Similar OECD 405 |
Not irritating |
Similar OECD 405 |
Not irritating |
|||
66455-14-9 |
500-165-3 |
Alcohols, C12-13, ethoxylated |
Similar OECD 405 |
Not irritating |
160901-19-9 |
500-457-0 |
Alcohols, C12-13, branched and linear, ethoxylated |
OECD 405 |
Not irritating |
Evaluation of eye irritation as observed in studies
All available study results indicate a generally low irritation potential of the AE substances towards the eye. Effects observed (if any) on corneal opacity, iridial and conjunctival irritation as well as chemosis were mainly mild and fully reversible within the observation period of the respective study. The mean scores determined in the studies are below the threshold for classification according to the criteria of the CLP Regulation (EC) No. 1272/2008. Only one of the two studies performed with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) resulted in irreversible effects indicating a potential to cause serious eye damage whereas in the other study no eye irritation was observed. However, in the study demonstrating corrosion only one animal was used and it is the only study, out of the nine available studies, contradicting the general trend within the AE category. Based on all available experimental data on eye irritation in the AE category, it is therefore concluded not to consider the single study on only one animal demonstrating a potential for serious eye damage. Excluding this study, it is established that the length of the alkyl chain and the presence of unsaturated constituents do not exert any influence on the eye irritation potential of AE substances. However, experimental data regarding eye irritation for category members with a carbon-chain length < C12 are not available. Therefore, the eye irritation potential of AE member substances is also assessed based on the CESIO recommendation for the harmonised classification and labelling of surfactants (CESIO: the European Committee of Organic Surfactants and their Intermediates; www.cesio.eu/index.php/policy-legislation/classification-labelling). The CESIO approach also considers AE substances which are not members of the AE category, thus increasing the database for assessing the eye irritation potential. In summary, adequate and reliable studies performed with category member substances (with ≥ C12) in combination with the CESIO recommendation for AE member substances with < C12 allow to conclude that category member substances containing at least one constituent with alkyl chain lengths < C12 exhibit an eye irritation potential whereas AE substances containing only constituents with an alkyl chain length of ≥ C12 are not irritating to the eye.
This evaluation is considered sufficiently conclusive for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the eye irritation potential of the substances in the AE category, please refer to the category justification attached to the category object.
Justification for classification or non-classification
The available data on skin and eye irritation obtained with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) and with other members of the Alcohol Ethoxylates (AE) category containing only saturated constituents and carbon-chain lengths ≥ C12 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.
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