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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Referenceopen allclose all

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.

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
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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.

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
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.

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
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.

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.

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.

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.