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EC number: 500-213-3 | CAS number: 68439-50-9 1 - 2.5 moles ethoxylated
- 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
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- 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, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) 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 alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) 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:
- 16 - 31 May 1988
- 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
- Deviations:
- yes
- Remarks:
- occlusive dressing
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- yes
- Remarks:
- no sequential testing approach; occlusive dressing
- 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: 2.2 kg
- Housing: Individual housing in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Speziafutter 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 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- 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: The test item was applied to a test area of approx. 6 cm² on the dorso lateral part of the trunk, covered with a gauze patch (2.5 x 2.5 cm) and covered with a piece of polyethylene foil.
- Type of wrap if used: The patch was hold in place with an elastic bandage.
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 and #3
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- One hour after administration, 2/3 animals showed moderate to severe erythema (score 3) and 1/3 rabbits showed well-defined erythema (score 2). In addition, slight edema (2/3 rabbits) and very slight edema (1/3 rabbits) was observed. At the 24 h reading, moderate to severe erythema (score 3) was noted in 2/3 animals and severe erythema to slight eschar formation (score 4) was noted in 1/3 animals. In addition, severe edema were observed in 2/3 rabbits (score 4) and moderate edema (score 3) was noted in 1/3 rabbits. The findings became more severe in time, as all 3 rabbits showed severe erythema to slight eschar formation (score 4) and severe edema (score 4) at the 48 and 72 h reading. Erythema and edema were no longer observed in the animals on Day 6, however, scales were observed in all 3 animals, which persisted in 2/3 animals until Day 10 and in 1/3 animals until study termination on Day 14.
- Interpretation of results:
- study cannot be used for classification
- Executive summary:
The classification of the test material is based on a very rigorous treatment of the animals with the test material. Exposure to the test material under occlusive conditions is significantly higher than under the current OECD 404 prescribed exposure under semi-occluded conditions. Higher exposures will likely result in more severe effects. Hence, the results from this study overpredict the irritation potential when assessed against new OECD 404 guidance criteria.
- 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 findings observed during the 14 day 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 | 3 | 3 | 4 | 4 | - | - | - | - | 3.67 |
2 | 3 | 4 | 4 | 4 | - | - | - | - | 4.00 |
3 | 2 | 3 | 4 | 4 | - | - | - | - | 3.67 |
Table 2: Edema findings observed during the 14 day 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 | 2 | 3 | 4 | 4 | - | - | - | - | 3.67 |
2 | 1 | 4 | 4 | 4 | - | - | - | - | 4.00 |
3 | 2 | 4 | 4 | 4 | - | - | - | - | 4.00 |
Table 3: Skin irritation findings
Animal | 1 h | 24 h | 48 h | 72 h | 6 days | 8 days | 10 days | 14 days |
1 | x | x | x d | x d | scp | scp det | sc det | - |
2 | - | x | x d cr | x d cr | scp cr | scp det | sc det ns | sc det |
3 | - | x | x d cr | x d cr | scp cr | scp det ns | - | - |
x: yellow stained skin in the test area; d: dry skin; cr: cracked skin; scp: scabs; sc: scales; det: detaching, ns: new skin |
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:
- weight of evidence
- Study period:
- 24 - 30 May 1988
- 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 stepwise testing approach; 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. Kar1 Thomae GmbH, Biberach, Germany
- Weight at study initiation: 1.7 - 2.0 kg
- Housing: Individual housing in stainless steel cages
- Diet: K4 Alleindiat 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): warm physiological saline solution
- Time after start of exposure: 72 h
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:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- One hour after test item instillation, conjunctival redness was observed in all 3 animals. The finding persisted in 2/3 rabbits up to 24 h post administration and in 1/3 rabbits up to 48 h after instillation. Thereafter, the animals did no longer show any eye irritation effects. Corneal opacity, irits or conjunctival chemosis findings were not observed at any reading time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- 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
- Deviations:
- yes
- Remarks:
- only one animal tested; this is no deviation from the most current version of OECD guideline 405
- 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:
- yes
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Chbb:Hm
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2240 g
- Housing: Individually
- Diet: Altromin diet 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- single application without rinsing
- Observation period (in vivo):
- 21 days
Reading time points: 1, 6, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days - Number of animals or in vitro replicates:
- 1 (because strong reactions on the eyes were expected)
- Details on study design:
- SCORING SYSTEM: Draize scoring
TOOL USED TO ASSESS SCORE: Fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- The test substance revealed moderate effects on the cornea (corneal opacity score 1) which were not reversible within 21 days. The iridal effects (scores 1 and 2) persisted for 17 days whereas the conjunctival reactions (scores 1 and 2 for conjunctival redness and chemosis) observed were moderate and persisted for longer than 21 days.
- Interpretation of results:
- other: Eye damage 1, H318. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
- Endpoint:
- eye 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:
- cornea opacity score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not irritating based on all available eye irritation data in the Alcohol Ethoxylates (AE) category for substances with carbon-chain lengths ≥ C12.
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not irritating based on all available eye irritation data in the Alcohol Ethoxylates (AE) category for substances with carbon-chain lengths ≥ C12.
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not irritating based on all available eye irritation data in the Alcohol Ethoxylates (AE) category for substances with carbon-chain lengths ≥ C12.
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Not irritating based on all available eye irritation data in the Alcohol Ethoxylates (AE) category for substances with carbon-chain lengths ≥ C12.
- 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 eye irritating potential is predicted for the target substance.
- Executive summary:
The available data on eye irritation in the Alcohol Ethoxylates (AE) category indicate no eye 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 eye irritation potential.
Referenceopen allclose all
Table 1: Eye irritation results
Rabbit | Corneal opacity | Iris | Conjunctival redness | Conjunctival chemosis | ||||||||
1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
1 h | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
48 h | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
72 h | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 days | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Mean 24/48/72 h | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.67 | 0.00 | 0.33 | 0.00 | 0.00 | 0.00 |
Table 1: Results of the eye irritation study
Reading | Corneal Opacity | Iris | Conjunctival redness | Conjunctival chemosis |
1 h | 1 | 0 | 1 | 1 |
6 h | 1 | 0 | 2 | 2 |
24 h | 1 | 0 | 2 | 2 |
48 h | 1 | 1 | 2 | 1 |
72 h | 1 | 1 | 2 | 1 |
7 days | 1 | 2 | 2 | 1 |
10 days | 1 | 2 | 2 | 1 |
14 days | 1 | 2 | 2 | 1 |
17 days | 1 | 1 | 2 | 1 |
22 days | 1 | 0 | 2 | 1 |
Mean 24/48/72 h | 1.00 | 0.67 | 2.00 | 1.33 |
For a detailed assessment of the eye irritation 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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
Data on skin irritation / corrosion are available for alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) as well as several member substances of the Alcohol Ethoxylates (AE) category.
Study with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3)
The skin irritation potential of alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) was investigated in vivo in a study similar to OECD guideline 404 (Sasol, 1988a). 0.5 mL of the undiluted test substances was applied for 4 h to the shaved skin of three albino rabbits (Kleine weiße Russen) under occlusive conditions. Skin reactions were observed 1, 24, 48 and 72 h as well as 6, 8, 10 and 14 days after application. The test substance induced significant skin reactions in all animals. The mean 24/48/72 h oedema and erythema scores were 3,67, 4 and 3.67 for animal #1, #2 and #3, respectively. The skin reactions were not fully reversed within the 14 day observation period. The findings of the study indicate that the test substance is severely irritating to the skin. However, the classification for skin irritation would be based on a very rigorous treatment of the animals with the test material. Exposure under occlusive conditions is significantly higher than under the current OECD 404 prescribed exposure under semi-occluded conditions. Higher exposures will most likely result in more severe effects. Hence, the results from this study over predict the irritation potential when assessed against new OECD 404 guidance criteria and classification of the test material is not justified, especially when taking further studies with AE substances into account as discussed below.
Studies in the AE category
Adequate and reliable studies on skin irritation are available for the following AE members:
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, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) as well as several member substances of the AE category.
Studies with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3)
The irritating potential of alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) to the eyes was tested according to OECD guideline 405. In a first study only the eye of a single rabbit (strain: Kleinrusse) was treated with 0.1 mL unchanged test substance without rinsing. Eye reactions were scored according to Draize at several time points for 21 days (BASF, 1988a). The test substance revealed moderate effects on the cornea which were not reversible within 21 days. The iridial effects persisted for 17 days whereas the conjunctival reactions observed were moderate and persisted for longer than 21 days. As findings were not reversible within 21 days the substance is corrosive according to this study. However, in a second study, the eye of three rabbits (strain: Kleine weiße Russen) was treated with 0.1 mL unchanged test substance without rinsing (Sasol, 1988b). Eye reactions were scored according to Draize at several time points for 6 days. The mean 24, 48, 72 h cornea, iris, conjunctiva and chemosis score of all animals was 0, 0, 0.3 and 0, respectively. The conjunctival findings reversed by day 6. Therefore the substance is not eye irritating according to this study. The findings of the latter study are further supported taking all available data on eye irritation in the AE category into account.
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, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) 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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