Alcohols, C8-18, ethoxylated

Endpoint summary

Description of key information

Skin Irritation:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal irritation potential for target substance.

Alcohols, C8-18, ethoxylated  can be estimated to be irritating to skin.

Eye Irritation:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the ocular irritation potential of Alcohols, C8-18, ethoxylated. Alcohols, C8-18, ethoxylated  was estimated to be irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Weight of evidence approach based on structurally and functionally similar substances

Justification for type of information:

Weight of evidence approach based on structurally and functionally similar substances

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on structurally and functionally similar substances

Principles of method if other than guideline:

The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal irritation potential of Alcohols, C8-18, ethoxylated (1 - 2.5 moles ethoxylated)

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material: Alcohols, C8-18, ethoxylated
- IUPAC name: Alcohols, C8-18, ethoxylated (1 - 2.5 moles ethoxylated)
- Molecular formula: (Cx-y AEn) or (C8-18 AE1- 2.5)
- Substance type: Organic
- Physical state: Liquid (viscous)

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data available

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

1. 0.5 ml undiluted test chemical
2. undiluted
3. 0.5 ml

Duration of treatment / exposure:

1. single exposure
2. 4 hours
3. 24 hours

Observation period:

1. 24,72 hours
2. 24 hours till 14 days
3. 72 hours

Number of animals:

1. 6
2. 3
3. 6

Details on study design:

The study was based on weight of evidence approach from the read across values

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

signs of irritation observed

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the dermal irritation potential for target substance.
Alcohols, C8-18, ethoxylated can be estimated to be irritating to skin.

Executive summary:

Based on the available studies for the structurally and functionally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential ofAlcohols, C8-18, ethoxylated.

 

A Primary skin irritation test was carried out to assess the irritation potential of the structurally and functionally similar read across chemical in rabbits.

0.5 ml of undiluted test chemical was applied under occlusion to the clipped, intact and abraded skin of 6 rabbits and observed for signs of irritation. The sites were individually examined at 24 h and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24- and 72-hours gradings were averaged to determine the Primary Irritation Index (PII).

The Primary Irritation Index for the test chemical was 2.0 after 24, 72 hours.

Based on the scores, the test chemical was moderately irritating to rabbit skin.

 

This result is supported by the results of the Primary skin irritation test carried out to assess the irritation potential of the structurally and functionally similar read across chemical in rabbits.

The study was performed in accordance with OECD 404 Guidelines. Undiluted test chemical was applied to clipped dorsal skin of 3 rabbits under semi-occlusive conditions for 4 hours. The rabbits were observed for effects till 14 days and assessed.The test chemical caused very slight erythema at all dermal test sites one hour of post-dosing and well-defined erythema at two of the dermal test sites within 24 hours after patch removal.

All erythema resolved within 14 days after dosing. Desquamation affected all dermal test sites on the eighth day of observation but this dermal change resolved before termination of the study.

The PII was calculated to be 1.3.

Based on the scores and observations, the test chemical was considered to be mildly irritating to rabbit skin.

 

The above results are supported by the results of the Patch tests performed by the method of Draize to determine the dermal irritation potential of the structurally and functionally similar read across chemical. 0.5ml undiluted test chemical was applied to shaven intact and abraded back of 6 albino rabbits. Patches are taped over the exposure sites and the trunk of the animal was wrapped with plastic. The rabbits were exposed to the test chemical for 24 hours. The patches were removed after 24 hours and the backs were then washed and the sites are rescored after 72 hours. The sites were scored for both erythema (reddening) and edema (swelling) on a basis of weighted scores of 0 (non-irritating) to 4 (severe reaction) for a total score, referred to as the Primary Irritation Index, of up 10 8. The Primary Irritation Index was the average score of the test group as a whole.Undiluted test chemical caused severe irritation to skin.

Hence the test chemical was considered to be irritating to skin.

 

Based on the available data for the structurally, functionally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be irritating to skin and it can be further classified under the category “Category 2” as per CLP regulation.

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Weight of evidence approach based on structurally and functionally similar chemicals

Justification for type of information:

Weight of evidence approach based on structurally and functionally similar chemicals

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: Weight of evidence approach based on structurally and functionally similar chemicals

Principles of method if other than guideline:

Weight of evidence approach based on structurally and functionally similar chemicals

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material: Alcohols, C8-18, ethoxylated
- IUPAC name: Alcohols, C8-18, ethoxylated (1 - 2.5 moles ethoxylated)
- Molecular formula: (Cx-y AEn) or (C8-18 AE1- 2.5)
- Substance type: Organic
- Physical state: Liquid (viscous)

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

1. Single dose of 0.005, 0.02, 0.10, or 0.5 ml undiluted test chemical
2. not specified

Duration of treatment / exposure:

1. single exposure
2. 7 days

Observation period (in vivo):

1. within 1 h unstained and at 24 h after fluorescein staining ; 1, 2, 3, 4 and 7 days post –instillation
2. 7 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

6

Details on study design:

The study is based on weight of evidence approach from the read across values

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Signs of irritation observed

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

On the basis of available studies for the structurally similar read across substances, the weight of evidence approach was applied to assess the ocular irritation potential of Alcohols, C8-18, ethoxylated. Alcohols, C8-18, ethoxylated was estimated to be irritating to eyes.

Executive summary:

Based on the available studies for the structurally and functionally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential ofAlcohols, C8-18, ethoxylated.

 

A Primary eye irritation test was carried out to assess the irritation potential of the structurally and functionally similar read across chemical in rabbits.

Single dose of 0.005, 0.02, 0.10, or 0.5 ml of undiluted test chemical was instilled into the conjunctival sac of 6 (male and female) rabbits. The treated eyes remained unwashed throughout the test. The eyes were examined within 1 h unstained and at 24 h after fluorescein staining. The rabbits were observed for signs of irritation at 1, 2, 3, 4 and 7 days post –instillation of the test chemical. The reactions observed were scored according Draize method.

The Primary Irritation Index for the test chemical was 3.7 after 24hours.

Based on the scores, the test chemical was considered to be minimal irritant to rabbit eyes.

 

This is supported by the results of the Primary Ocular irritation test conducted in rabbits according to Draize method to evaluate the irritation potential of the structurally and functionally similar read across chemical.6 rabbits were used for the study and the eyes were not rinsed. The eye reactions were scored according the Draize method (scales 0 to 110).

The average Draize scores on days 1 and 7 post-instillation were 28.8 and 16.0, respectively.

Based on the scores, the test chemical can be considered to be a severe ocular irritant.

 

Based on the available data for the structurally, functionally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.

 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

Based on the available studies for the structurally and functionally similar read across chemicals, weight of evidence approach was applied to assess the dermal irritation potential ofAlcohols, C8-18, ethoxylated.

 

A Primary skin irritation test was carried out to assess the irritation potential of the structurally and functionally similar read across chemical in rabbits.

0.5 ml of undiluted test chemical was applied under occlusion to the clipped, intact and abraded skin of 6 rabbits and observed for signs of irritation. The sites were individually examined at 24 h and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24- and 72-hours gradings were averaged to determine the Primary Irritation Index (PII).

The Primary Irritation Index for the test chemical was 2.0 after 24, 72 hours.

Based on the scores, the test chemical was moderately irritating to rabbit skin.

 

 

This result is supported by the results of the Primary skin irritation test carried out to assess the irritation potential of the structurally and functionally similar read across chemical in rabbits.

The study was performed in accordance with OECD 404 Guidelines. Undiluted test chemical was applied to clipped dorsal skin of 3 rabbits under semi-occlusive conditions for 4 hours. The rabbits were observed for effects till 14 days and assessed.The test chemical caused very slight erythema at all dermal test sites one hour of post-dosing and well-defined erythema at two of the dermal test sites within 24 hours after patch removal.

All erythema resolved within 14 days after dosing. Desquamation affected all dermal test sites on the eighth day of observation but this dermal change resolved before termination of the study.

The PII was calculated to be 1.3.

Based on the scores and observations, the test chemical was considered to be mildly irritating to rabbit skin.

 

The above results are supported by the results of the Patch tests performed by the method of Draize to determine the dermal irritation potential of the structurally and functionally similar read across chemical. 0.5ml undiluted test chemical was applied to shaven intact and abraded back of 6 albino rabbits. Patches are taped over the exposure sites and the trunk of the animal was wrapped with plastic. The rabbits were exposed to the test chemical for 24 hours. The patches were removed after 24 hours and the backs were then washed and the sites are rescored after 72 hours. The sites were scored for both erythema (reddening) and edema (swelling) on a basis of weighted scores of 0 (non-irritating) to 4 (severe reaction) for a total score, referred to as the Primary Irritation Index, of up 10 8. The Primary Irritation Index was the average score of the test group as a whole.

Undiluted test chemical caused severe irritation to skin.

Hence the test chemical was considered to be irritating to skin.

 

Based on the available data for the structurally, functionally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be irritating to skin and it can be further classified under the category “Category 2” as per CLP regulation.

Eye Irritation:

Based on the available studies for the structurally and functionally similar read across chemicals, weight of evidence approach was applied to assess the ocular irritation potential of Alcohols, C8-18, ethoxylated.

 

A Primary eye irritation test was carried out to assess the irritation potential of the structurally and functionally similar read across chemical in rabbits.

Single dose of 0.005, 0.02, 0.10, or 0.5 ml of undiluted test chemical was instilled into the conjunctival sac of 6 (male and female) rabbits. The treated eyes remained unwashed throughout the test. The eyes were examined within 1 h unstained and at 24 h after fluorescein staining. The rabbits were observed for signs of irritation at 1, 2, 3, 4 and 7 days post –instillation of the test chemical. The reactions observed were scored according Draize method.

The Primary Irritation Index for the test chemical was 3.7 after 24hours.

Based on the scores, the test chemical was considered to be minimal irritant to rabbit eyes.

 

This is supported by the results of the Primary Ocular irritation test conducted in rabbits according to Draize method to evaluate the irritation potential of the structurally and functionally similar read across chemical.6 rabbits were used for the study and the eyes were not rinsed. The eye reactions were scored according the Draize method (scales 0 to 110).

The average Draize scores on days 1 and 7 post-instillation were 28.8 and 16.0, respectively.

Based on the scores, the test chemical can be considered to be a severe ocular irritant.

 

Based on the available data for the structurally, functionally similar read across substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.

 

Justification for classification or non-classification

The results of the experimental studies from the structurally, functionally similar read across substances indicate a possibility that Alcohols, C8-18, ethoxylated can be irritating to skin and eyes.

Hence by applying the weight of evidence approach, Alcohols, C8-18, ethoxylated can be considered to be irritating to skin and eyes. It can be classified under the category “Category 2” as per CLP regulation.