Poly(oxy-1,2-ethanediyl), .alpha.-sulfo-.omega.-hydroxy-, C8-10-alkyl ethers, sodium salts

Endpoint summary

Description of key information

Skin corrosion (in vitro, OECD 431): not corrosive

Skin irritation (in vitro, OECD 439): irritating or corrosive

Hazard conclusion: irritating

Conclusion based on data with alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2).

 

Eye irritation: serious eye damage

Read-across based on grouping of substances (category approach) considering all available data on eye irritation in the AES category in a Weight-of-Evidence approach.

Specific Concentration Limits (SCL):

5% - <10% Eye Irrit. 2, H319

< 5% No Classification

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

adopted in 2010

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: EpiDerm™

Source strain:

other: not applicable (human skin model)

Details on animal used as source of test system:

not applicable (human skin model)

Justification for test system used:

The used test system is in line with OECD TG 439.

Vehicle:

unchanged (no vehicle)

Details on test system:

An in-vitro study with the EpiDermTM human skin model comprising a reconstructed epidermis with a functional stratum corneum was performed. The EpiDermTM tissues were obtained by MatTek. The tissue was moistened with 25 µL DPBS (Dulbecco`s Phosphate Buffered Saline) to ensure good skin contact before 25 mg of the test substance were applied directly atop the EpiDermTM tissue. DPBS was used as negative control while 5% SDS (Sodium dodecyl sulfate) was used as positive control. A total of 3 tissues per dose group were used in duplicate. Irritation properties of the test substance are identified by the decrease of cell viability after exposure as determined by using the MTT reduction assay. The tissues were maintained at 37 °C in humidified atmosphere (5% CO2/95% air). All media used during the study (for instance the incubation medium and MTT medium) were pre-warmed. After treatment, tissues were incubated at 37 °C in humidified atmosphere for 35 min and placed at room temperature thereafter. After 60 min the tissues were washed with DPBS, placed in pre-warmed incubation medium and were further incubated for 24 h at 37 °C in humidified atmosphere. After a medium change the tissues were incubated for additional 18 h prior to incubation in MTT medium for 3 h. After incubation in MTT the tissues were three times rinsed with DPBS before extraction of the reduced MTT with isopropanol for 2 hours. Per each tissue two aliquots of the extract were transferred into 96-well plates and analysed in a plate spectrophotometer. The MTT reducing potential and the coloring potential of the test substance as possible confounding factors were assessed.
Assessment criteria:
A test substance is concluded to be irritating if the relative mean tissue viability after 60 minute exposure and 42 hours post-treatment incubation is below 50%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Irritation / corrosion parameter:

% tissue viability

Remarks:

mean value of all tissues

Run / experiment:

60 min exposure

Value:

6.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

Reversibility: not applicable.

Other effects / acceptance of results:

The test item showed irritating potential (for details, see Table 1). However, only two experiments with test item treated tissues instead of three were evaluated due to loss of one tissue during washing. As each experiment was performed in duplicate 4 tissues were assessed. The test meets the acceptance criteria (See: Any other information on materials and methods incl. tables.)

Table 1: Summary of results

Test group	n	Treatment period (min)	Mean OD550value	Viability (%)	Mean inter tissue viability difference (%)
Negative control	3	60	1.78	100	15.8
Test item	2*	60	0.12	6.8	0.8
Positive control	3	60	0.12	6.6	0.9

* Only two test item treated tissues instead of three were evaluated due to loss of one tissue during washing.

Interpretation of results:

other: Skin irrit. 2 (H315) according to Regulation (EC) No 1272/2008

Conclusions:

There is regulatory acceptance in the EU that a substance can be considered non-irritant and non-corrosive based on a negative result in the Reconstructed human epidermis test method (in vitro skin irritation). A positive in vitro irritation response is not conclusive with respect to classification of the test substance as irritant (Skin Irritant Cat. 2) or corrosive or Skin Corrosive Cat. 1) and therefore requires further evaluation and/or data generation. Previously, an in vitro skin corrosion test was conducted (Study-ID: 122043) with the result "non-corrosive". The outcome of the present skin irritation test is positive. Thus, taken together the results from both tests, it can be concluded that the substance meets the criteria as a Skin Irritant Cat. 2 (H315).

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

adopted in 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test system:

human skin model

Remarks:

EpiDerm™

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: EpiDerm™

Source strain:

other: human skin model

Details on animal used as source of test system:

not applicable (human skin model)

Justification for test system used:

The used test system is in line with OECD TG 431.

Vehicle:

unchanged (no vehicle)

Details on test system:

An in-vitro study with the EpiDerm™ human skin model comprising a reconstructed epidermis with a functional stratum corneum was performed. The EpiDerm™ tissues were obtained by MatTek. 25 mg of the test substance were applied directly atop the EpiDerm™ tissue. The test substance was moistened with 25 µL water to ensure good skin contact. Distilled water was used as negative control while 8 N KOH was used as positive control. A total of 4 tissues per dose group and 2 replicates per treatment period (3 and 60 minutes) were used. Corrosive properties of the test substance are identified by the decrease of cell viability after exposure as determined by using the MTT reduction assay.
The tissues were maintained at 37°C in humidified atmosphere (5% CO2/95% air) and maintenance during preparation and treatment was appropriate. All media used during the study (for instance the incubation medium and MTT medium) were pre-warmed. Tissues were rinsed with PBS before incubating in MTT medium for 3 h at 37°C in humidified atmosphere. After incubation in MTT the tissues were again rinsed with PBS before extraction of the reduced MTT with isopropanol for 2 hours in sealed bags. Per each tissue three aliquots of the extract were transferred into 96-well plates and analysed in a plate spectrophotometer.
The MTT reducing potential and the coloring potential of the test substance as possible confounding factors were assessed.

INTERPRETATION OF TEST RESULTS:
A test substance is concluded to be non-corrosive if the relative mean tissue viability after 3 minute treatment is above 50% and above 15% after 60 minutes.
A test substance is considered to be corrosive if the viability after 3 minutes is at or below 50% and below 15% after 60 minutes treatment.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg

Duration of treatment / exposure:

3 and 60 min

Number of replicates:

2 replicates per treatment period

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 min

Value:

84

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 min

Value:

48

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The test item showed no corrosive potential. The test mets the acceptance criteria (for details see any other information on results).

Table 1: Summary of results

Test group	Treatment period (min)	Mean OD550value	Viability (%)	Mean inter tissue viability difference (%)
Negative control	3	2.12	100	8.3
Test item	3	1.781	84	24.3
Positive control	3	0.355	17	15.1
Negative control	60	2.174	100	0.8
Test item	60	1.036	48	23.8
Positive control	60	0.204	9	18.7

The mean OD value of the two negative control tissues of the 3 and 60 minute treatment period is above 0.8. The mean relative tissue viability of the two positive controls of the 3 minute treatment period is below 30%. The maximum inter tissue viability difference between tissues treated identically is below 30%.

Interpretation of results:

other: non-corrosive

Conclusions:

Under the present test conditions, the substance tested at the two exposure periods 3 and 60 minutes was non-corrosive to reconstructed human epidermis tissue in the Epiderm™ model. There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat.1A) based on a positive result in the human epidermis model test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant and shall therefore be subject to further evaluation (see study ID: 121484).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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.

Irritation parameter:

cornea opacity score

Time point:

24/48/72 h

Remarks on result:

other: Serious eye damage based on all available eye irritation data in the Alkyl Ether Sulfates (AES) category.

Irritation parameter:

iris score

Time point:

24/48/72 h

Remarks on result:

other: Serious eye damage based on all available eye irritation data in the Alkyl Ether Sulfates (AES) category.

Irritation parameter:

conjunctivae score

Time point:

24/48/72 h

Remarks on result:

other: Serious eye damage based on all available eye irritation data in the Alkyl Ether Sulfates (AES) category.

Irritation parameter:

chemosis score

Time point:

24/48/72 h

Remarks on result:

other: Serious eye damage based on all available eye irritation data in the Alkyl Ether Sulfates (AES) category.

For a detailed assessment of the eye irritation potential of the Alkyl Ether Sulfates (AES) category, please refer to the category justification attached to the category object.

Interpretation of results:

other: Eye damage 1, H318. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).

Conclusions:

Applying read-across based on grouping of substances (category approach), a potential to induce serious eye damage is predicted for the target substance.

Executive summary:

The available data on eye irritation in the Alkyl Ether Sulfates (AES) category indicate a potential to induce serious eye damage 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 AES category are unlikely to lead to differences in the eye irritation potential.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

Data on skin irritation / corrosion are available for alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2) as well as several member substances of the Alkyl Ether Sulfates (AES) category.

 

Studies with alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2)

The skin corrosion potential of alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2) was tested in an in-vitro study with the EpiDerm™ human skin model comprising a reconstructed epidermis with a functional stratum corneum according to OECD guideline 431 under GLP conditions (Z&S, 2012c). 25 mg of the test substance were applied directly to the EpiDerm™ tissue. The test substance was moistened with 25 µL water to ensure good skin contact. Distilled water was used as the negative control while 8 N KOH was used as the positive control. A total of 4 tissues per dose group and 2 replicates per treatment period (3 and 60 min) were used. Corrosive properties of the test substance were identified by the decrease of cell viability after exposure as determined by using the MTT reduction assay. The tissues were maintained at 37 °C in a humidified atmosphere (5% CO₂/95% air) and maintenance during preparation and treatment was appropriate. All media used during the study were pre-warmed. Tissues were rinsed with Phosphate-Buffered Saline (PBS) before incubating in MTT medium for 3 h at 37 °C in a humidified atmosphere. After incubation in MTT medium, the tissues were again rinsed with PBS before extraction of the reduced MTT with isopropanol for 2 h in sealed bags. For each tissue 3 aliquots of the extract were transferred into 96-well plates and analysed in a plate spectrophotometer. The MTT reducing potential and the colouring potential of the test substance as possible confounding factors were assessed. A test substance is concluded non-corrosive if the relative mean tissue viability after 3 min treatment is > 50% and > 15% after 60 min and it is considered corrosive if the viability after 3 min is ≤ 50% and < 15% after 60 min treatment. The viability of the treated tissue, as assessed via the MTT assay, was 84% and 48% of control after 3 and 60 min exposure, respectively. Therefore, under the present test conditions and based on the evaluation criteria of the study, alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2) was non-corrosive to reconstructed human epidermis tissue in the EpiDerm™ model.

There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corr. 1A) based on a positive result in the human epidermis model test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant. Therefore, an in-vitro study with the EpiDerm™ human skin model comprising a reconstructed epidermis with a functional stratum corneum according to OECD guideline 439 and observing GLP criteria was performed (Z&S, 2012d). The tissue was moistened with 25 µL Dulbecco`s Phosphate Buffered Saline (DPBS) to ensure good skin contact before 25 mg of the test substance were applied directly on the EpiDerm™ tissue. DPBS was used as the negative control while 5% sodium dodecyl sulfate (SDS) was used as the positive control. A total of 3 tissues per dose group were used in duplicate. Irritation properties of the test substance were identified by the decrease of cell viability after exposure as determined by using the MTT reduction assay. The tissues were maintained at 37 °C in a humidified atmosphere (5% CO₂/95% air). All media used during the study were pre-warmed. After treatment, tissues were incubated at 37 °C in a humidified atmosphere for 35 min and placed at room temperature thereafter. After 60 min the tissues were washed with DPBS, placed in pre-warmed incubation medium and were further incubated for 24 h at 37 °C in a humidified atmosphere. After a medium change the tissues were incubated for additional 18 h prior to incubation in MTT medium for 3 h. After incubation in MTT the tissues were rinsed three times with DPBS before extraction of the reduced MTT with isopropanol for 2 h. For each tissue two aliquots of the extract were transferred into 96-well plates and analysed in a plate spectrophotometer. The MTT reducing potential and the colouring potential of the test substance as possible confounding factors were assessed. A test substance is concluded to be irritating if the relative mean tissue viability after 60 min exposure and 42 h post-treatment incubation is < 50%. The viability of the treated tissue was found to be 6.8% of control. However, only two experiments with test item treated tissues instead of three were evaluated due to loss of one tissue during washing. As each experiment was performed in duplicate, 4 tissues were assessed and the test met the acceptance criteria of the method. The test substance, alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2) was identified to be irritating or corrosive to reconstructed human epidermis tissue in the EpiDerm™ model.

The combined results of the two in vitro studies lead to the conclusion that alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2) shows skin irritation potential and should be classified as Skin Irrit. 2 (H315).

 

Studies in the AES category

Additional studies on skin irritation / corrosion are available for the following AES substances:

 

Table 1: Database on skin irritation / corrosion in the Alkyl Ether Sulfates (AES) category

CAS / EC Nos.	Substance	Study or Report No.	Study protocol (adopted in)	Concentration in test material [%]	Hazard conclusion
‘Linear’ subgroup
68585-34-2 / 500-223-8	Alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, sodium salts	000504/1	Similar OECD 404	68	Irritating
		82-003E	Similar OECD 404	25	Irritating
		82-003B	Similar OECD 404	25 - 30	Irritating
		A/S/12431	Similar OECD 404	70	Irritating
		18957	OECD 404	58.5	Irritating
		4299	Similar OECD 404	10	Not irritating
		4306	Similar OECD 404	1	Not irritating
68891-38-3 / 500-234-8	Alcohols, C12-14, ethoxylated, sulfates, sodium salts	R9400637	OECD 404	70	Irritating
		TBD860073	Similar OECD 404	25	Irritating
		3108	Similar OECD 404	28	Not irritating
		2976	Similar OECD 404	70	Irritating
		000504/1	Similar OECD 404	68	Irritating
		3116	Similar OECD 404	1	Not irritating
		R9400325	OECD 404	70.1	Corrosive
		256/8409	Similar OECD 404	70	Irritating
		R9600430	OECD 404	27	Irritating
		86498D/UGF 17/SE	Similar OECD 404	70	Irritating
		Hoe88.0919	Similar OECD 404	69	Irritating
174450-50-1 / 605-725-1	Alcohols C12-14 (even numbered), ethoxylated (< 2.5 EO), sulphated, triisopropanolamine salts	2397	OECD 404	83.8	Irritating
Mixed branched & linear’ subgroup
160901-28-0 / 500-465-4	Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts	219-7703	Similar OECD 404	30	Irritating

 

Evaluation of skin irritation / corrosion as observed in studies

The concentration of AES substances in the test materials used in the skin irritation / corrosion studies varies from 1% to approx. 100%. Tested AES substances induced mostly moderate to severe erythema and oedema at concentrations above 25%. Irritation symptoms started to occur immediately after removal of the test substance and were usually reversible within the 21-day observation period of the respective studies. However, since in some studies observations were made for a period less than the maximum of 21 days, skin effects were still observed at the termination of most of these studies. AES concentrations ≤ 10% did not cause irritation (studies 4299 and 4306 with alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, sodium salts, CAS No. 68585-34-2, EC No. 500-223-8). The only exception to this finding was one of the in vivo studies with alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS No. 68891-38-3, EC No. 500-234-8, study No. 3108) in which the substance was tested at a concentration of 28% and induced only very weak erythema which was fully reversible within the 8-day observation period. No oedema was observed in this study. The reason for this deviation from the general observation is unknown. In some studies, the exposure period was 24 h and/or an occlusive cover was used. Only one of the available studies revealed a corrosive potential (study no. R9400325 performed with alcohols, C12-14, ethoxylated, sulfates, sodium salts. All other available studies indicate a potential to induce irritation. The reason for the corrosion found in study R9400325 is unknown. However, since it is the only study in the database of the category, it is considered not to contradict the overall conclusion of skin irritation for AES substances. The main findings of the in vivo studies are supported by the available in vitro assays performed with alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2). The combined results of the in vitro studies provide evidence for an irritating (but not corrosive) potential.

The WoE analysis based on the in vitro and in vivo studies indicates that AES substances in general exhibit a potential to induce skin irritation. This finding applies to all AES substances in the category, whether they belong to the ‘linear’, ‘unsaturated’ or ‘mixed branched & linear’ subgroups and it is fully supported by the OECD QSAR Toolbox profiling. The outcome of this overall WoE evaluation is used for the hazard assessment and to conclude on classification and labelling of all AES substances in the category. This evaluation is considered sufficient for the hazard assessment and classification and labelling of the AES substances. For a detailed evaluation of the skin irritation / corrosion potential of the substances in the AES category, please refer to the category justification attached to the category object.

 

Eye irritation

No data on eye irritation are available for alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2). In order to assess eye irritation potential, studies in the database of the Alkyl Ether Sulfates (AES) category are considered in a read-across approach. Studies investigating eye irritation are available for the following AES substances:

 

Table 2: Database on eye irritation in the Alkyl Ether Sulfates (AES) category

CAS / EC Nos.	Substance	Study or Report No.	Study protocol (adopted in)	Concentration in test material [%]	Hazard conclusion based on study report
‘Linear’ subgroup
68585-34-2 / 500-223-8	Alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, sodium salts	4298	Similar OECD 405	10	Serious eye damage
		97/10197-2	OECD 405	27	Not irritating
		RE80/159A	Similar OECD 405	58	Irritating
		28366	Similar OECD 405	69	Irritating
		4288	Similar OECD 405	25	Irritating
		4307	Similar OECD 405	24.3	Irritating
		4308	Similar OECD 405	1	Not irritating
		A/E/12323	Similar OECD 405	70	Not irritating
		97/9690-2	OECD 405	27	Irritating
		82-003C	Similar OECD 405	25 - 30	Irritating
		82-003F	Similar OECD 405	Not specified	Irritating
		19970	OECD 405	60	Serious eye damage
68891-38-3 / 500-234-8	Alcohols, C12-14, ethoxylated, sulfates, sodium salts	TBD890310	OECD 405	25	Serious eye damage
		3109	Similar OECD 405	28	Serious eye damage
		3117	Similar OECD 405	1	Not irritating
		261/8409	Similar OECD 405	70	Irritating
		Hoe88.1081	OECD 405	70	Serious eye damage
		R9600431	OECD 405	27 - 28	Irritating
		R9900359	OECD 405	27 - 28	Irritating
		97/10197-2	OECD 405	5.4	Not irritating
174450-50-1 / 605-725-1	Alcohols C12-14 (even numbered), ethoxylated (< 2.5 EO), sulphated, triisopropanolamine salts	2398	OECD 405	83	Serious eye damage

 

Evaluation of eye irritation as observed in studies

The concentration of AES substances in the tested materials ranges from 1% in the studies with alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, sodium salts (CAS No. 68585-34-2, EC No. 500-223-8) and alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS No. 68891-38-3, EC No. 500-234-8) to 83% applied in the study with alcohols C12-14 (even numbered), ethoxylated (< 2.5 EO), sulphated, triisopropanolamine salts (CAS No. 174450-50-1, EC No. 605-725-1). Most of the studies were performed with AES concentrations between 25% and 70%. Concentrations at or above 10% generally induce moderate to severe irritant responses in conjunctiva, iris and cornea and cause chemosis. Some studies were terminated while effects were still observed in one or several animals. Since the observation periods applied in the different studies were not always as defined in the current OECD guideline 405, a concluding evaluation with respect to the reversibility of effects could not always be made and a case-by-case evaluation was made to reach a hazard conclusion. The exceptions to the general finding of irritating / damaging properties at concentrations > 10% are the studies 97/10197-2 and A/E/12323 with alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, sodium salts (CAS No. 68585-34-2, EC No. 500-223-8). These studies resulted in ‘not irritating’ at concentrations of 27% and 70%, respectively. The reason for the deviation of the general irritating / damaging properties is not known. However, the studies contribute only to a minor extent to the hazard assessment of the whole AES category.

In the following studies severe eye damage was observed: 4298 (10% concentration) and 19970 (60% concentration) with alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, sodium salts (CAS No. 68585-34-2, EC No. 500-223-8), as well as TBD890310, 3109, and Hoe88.1081 with alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS No. 68891-38-3, EC No. 500-234-8) at concentrations of 25%, 28%, and 70%, respectively. There is no clear trend in the available data between the concentration of a substance and the severity of eye effects (measured as chemosis, and reaction in conjunctivae, cornea, and iris) and it is therefore not possible to predict when eye irritation turns into serious eye damage. Therefore, all AES substances at concentrations ≥ 10% are considered to induce serious eye damage. The studies 4308 with alcohols C10-16, ethoxylated (1-2,5 EO) sulphated, sodium salts (CAS No. 68585-34-2, EC No. 500-223-8) and 3117 with alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS No. 68891-38-3, EC No. 500-234-8) clearly demonstrate that highly diluted AES substances are not irritating anymore. Based on the fact that most of the available studies revealed an eye irritating rather than an eye damaging potential and that the lowest concentration inducing eye damage is 25%, it is considered justifiable to define a cut-off concentration for eye damage of 10%. Therefore, a cut-off value for the induction of severe eye damage is set at a concentration of ≥ 10% for all AES substances in the category. The cut-off value for inducing irritation is set at a concentration of ≥ 5%.

In conclusion, the WoE analysis based on all available studies on eye irritation indicates that AES substances generally exhibit a potential to induce severe eye damage at concentration ≥ 10%, eye irritation in the concentration range 5 - 10% and no irritation < 5%. This finding applies to all AES substances in the category, whether they belong to the ‘linear’, ‘unsaturated’ or ‘mixed branched & linear’ subgroups and it is fully supported by the OECD QSAR Toolbox profiling. The outcome of this overall WoE evaluation is used for the hazard assessment and to conclude on classification and labelling for all AES substances in the category. This evaluation is considered sufficient for the hazard assessment and classification and labelling of the AES substances. For a detailed evaluation of the skin irritation / corrosion potential of the substances in the AES category, please refer to the category justification attached to the category object.

 

Data on counter ions

The counter ions Na⁺, Mg²⁺ and NH₄⁺ are not associated with an irritating or corrosive potential. They have no effect on the irritation / corrosion potential of the substances in the AES category.

In vivo studies on skin and eye irritation with alcohols C12-14 (even numbered), ethoxylated (< 2.5 EO), sulphated, triisopropanolamine salts (CAS No. 174450-50-1, EC No. 605-725-1) revealed an irritating and corrosive potential, respectively. Since skin irritation and eye damage have been identified for all members of the AES category - either based on experimental data or predicted for those AES substances lacking own data - the impact of triisopropanolamine (TIPA) has already been accounted for.

For a detailed evaluation of a potential effect of the counter ions on the toxicological profiles of the AES member substances, please refer to the category justification attached to the category object.

Justification for classification or non-classification

The available data on skin irritation obtained with alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2) meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 as Skin Irrit. 2, H315.

 

With respect to eye irritation, the available data with members of the AES category meet the criteria for classification according to the CLP Regulation. Based on grouping of substances (category approach), alcohols, C8-10, ethoxylated, sulfates, sodium salts (CAS No. 1471312-55-6, EC No. 939-523-2) is  predicted to fulfil the classification criteria and is classified as Eye Damage 1, H318.