Decan-1-ol, ethoxylated

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): irritating 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 2, 1995 - July 27, 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted study performed according to established methodology

Qualifier:

according to guideline

Guideline:

other: EPA Guideline No. 81-5

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry; Lumberton, Texas
- Age at study initiation: Young adult
- Weight at study initiation: Males (2.050-2.900 kg); Females (2.625-3.200 kg)
- Housing: 1 per cage (Suspended, wire bottom, stainless steel)
- Diet (e.g. ad libitum): Purina Rabbit Chow; presented in measured amounts
- Water (e.g. ad libitum): Municipal water supply, available ad libitum from automatic
water system
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72° ± 5°F
- Humidity (%): 30 - 80 %
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of the undiluted test material

Duration of treatment / exposure:

4 hours

Observation period:

72 h

Number of animals:

6 (3 m / 3 f)

Details on study design:

The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least 8 x 8 cm. Only those animals with exposure areas free of pre-existing skin irritation or defects were selected for testing. A single intact exposure site was selected as the test site while the contralateral intact site served as a control site.

On Day 0, 0.5 mL of the undiluted test material was applied to each test site and covered with a surgical gauze patch measuring 2.5 x 2.5 cm and two single layers thick. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) and secured on both edges with . strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test material..

After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean wet cloth to remove as much residual test material as possible.

The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1/2, 24, 48 and 72 hours after washing.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

probability of weak irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema was present at each observation through 24 hours in three animals. Edema was not observed at any time throughout the study. No other signs of irritation were observed during the study.

Other effects:

none

                                                Erythema                            Edema                     

   Animal number    1/2 h        24 h       48 h       72 h       1/2 h        24 h       48 h       72 h

1 (m)                1              1            0            0            0            0              0        0

2 (m)                1              0            0            0            0            0              0        0

3 (m)                1              1            0            0            0            0              0        0

4 (f)                  1              0            0            0            0            0              0        0

5 (f)                  1              1            0            0            0            0              0        0

6 (f)                  1              0            0            0            0            0              0        0

m = male; f = female

Interpretation of results:

GHS criteria not met

Conclusions:

Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.

Executive summary:

The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material. The animals were individually housed, equilibrated in the laboratory, and released from quarantine prior to testing. Normal growth, appearance, and behavior during the equilibration period were factors used to select healthy animals for testing.

Each animal was prepared on the day prior to treatment by clipping the dorsal area of the trunk free of hair to expose an area at least 8 x 8 cm. Only those animals with exposure areas free of pre-existing skin irritation or defects were selected for testing. A single intact exposure site was selected as the test site while the contralateral intact site served as a control site.

On Day 0, 0.5 mL of the undiluted test material was applied to each test site and covered with a surgical gauze patch measuring 2.5 x 2.5 cm and two single layers thick. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) and secured on both edges with . strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test material..

After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean wet cloth to remove as much residual test material as possible.

The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1/2, 24, 48 and 72 hours after washing.

Very slight erythema was present at each observation through 24 hours in three animals. Edema was not observed at any time throughout the study.

Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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

Justification for type of information:

Please refer to the Analogue Approach Justification provided in Section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of 6 animals

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Source: CAS 68439-45-2, Sasol, 1994

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 68439-45-2, Sasol, 1994

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of 6 animals

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Source: CAS 68439-45-2, Sasol, 1994

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of 6 animals

Time point:

24/48/72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Source: CAS 68439-45-2, Sasol, 1994

Additional study for WoE approach:

CAS 66455-14-9: not irritating (Shell, 1979b)

CAS 68439-45-2: serious eye damage (Sasol, 1992b)

Interpretation of results:

other: Eye irrit. 2, H319. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

To cover the endpoint irritation of substance decan-1-ol, ethoxylated (1-2.5 moles EO) (CAS 26183-52-8), studies from similar substances were taken into account. Read-across is justified because of the structural similarity of the AE Members. The degree of ethoxylation has no impact on the irritation potential due to its narrow range (1-2.5) within the category. According to a voluntary industry programme to carry out Human and Environmental Risk Assessments on ingredients of household cleaning products (HERA) the irritation potential of AEs is decreasing with increasing ethoxylation degree. The lower ethoxylation level of EO 1 - 3, which includes all read-across substances, appeared to be more irritating (HERA, 2009). Since the category chemicals differ mainly from each other only by the number of -CH2- units (except for the unsaturated group), the category is very homogenous and it is assumed that each category member exhibits the same toxic mode of action.

Based on weight of evidence and interpolation on the given study reports the following subcategories for skin irritation can be derived:

Class I:          short chain AEO (C6-11) → not classified for skin irritation 

Class II:         detergent grade AEO (C12-15) → not classified for skin irritation

Class III:        saturated long chain AEO (C16-18) → not classified for skin irritation

Class IV:        unsaturated long chain AEO (C16/18 and C18 unsatd.) → Skin irrit. 2, H315

For further details please refer to the category justification in IUCLID section 13.

 

Exemplary study summaries are provided to assess the skin and eye irritating potential of decan-1-ol, ethoxylated (1 -2.5 moles EO).

Skin irritation

For the endpoint skin irritation a study on the registered substance decan-1-ol, ethoxylated (1-2.5 moels EO) (CAS 26183-52-8) is available.

The study was conducted on six New Zealand White rabbits, 3 male and 3 female, to determine the skin irritation potential of the test material.

0.5 mL of the undiluted test material was applied to each test site and covered with a surgical gauze patch measuring 2.5 x 2.5 cm and two single layers thick. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) and secured on both edges with . strips of tape to retard evaporation of volatile substances and to prevent possible ingestion of the test material..

After four hours, the patches and wrappings were removed. The test sites were gently washed with room temperature tap water and a clean wet cloth to remove as much residual test material as possible.

The test sites were observed for erythema and edema formation, and any other dermal defects or irritation at 1/2, 24, 48 and 72 hours after washing.

Very slight erythema was present at each observation through 24 hours in three animals. Edema was not observed at any time throughout the study.

Reported skin irritation results for the test animals do not meet the criteria for irritant or mild irritant under GHS.

Eye irritation

Based on a weight of evidence approach decan-1-ol, ethoxylated (1-2.5 moles EO) (CAS 26183-52-8) does not meet the criteria for eye irritation according to Directive 67/548/EEC (DSD). According to Regulation (EC) No 1272/2008 (CLP) decan-1-ol, ethoxylated (1-2.5 moles EO) (CAS 26183-52-8) needs to be classified for Eye Irritation Category 2, H319. This classification is the result of a trend analysis performed for eye irritating properties of the members of the AE Category to evaluate the impact of carbon chain length distribution on the eye irritating properties. All available studies, performed according to OECD Guideline 405 under GLP conditions, applying AE of a high purity (>95%) and an ethoxylation degree ≤ 2.5 and allowing the evaluation of recovery (until day 21), were evaluated. According to this evaluation AE of the AE Category having a carbon chain length ≥ C12 do not need to be classified for eye irritation/severe eye irritation while AE having a carbon chain length < C12 need to be classified for Eye Irritation Category 2.

Based on this analysis decan-1-ol, ethoxylated (1-2.5 moles EO) (CAS 26183-52-8) is not classified for eye irritation according to DSD but for Eye Irritation Category 2 according to CLP. For further information please refer to the category justification.

To investigate the eye irritating potential of the lower carbon chain length of C10 AE, a study with C6-10 AE (CAS 68439-45-2) conducted according to OECD Guideline 405 (Sasol, 1994) was chosen for read-across. Six rabbits were treated with 0.1 mL of undiluted test substance without rinsing. Based on the mean 24, 48 and 72 h scores no classification according to DSD is required. However, according to CLP the test substance does need to be classified for Eye Irritation Category 2. The test substance revealed moderate effects on the cornea which were reversible within 7 days. No effects on the iris were observed whereas the conjunctival reactions observed were moderate and persisted for a maximum of 10 days.

 

A further OECD Guideline 405 study was conducted with C8-10 AE (CAS 68439-45-2). Six rabbits were treated with 0.1 mL of undiluted test substance without rinsing (Sasol, 1992b). Based on the mean 24, 48 and 72 h scores no classification according to DSD is required. However, according to CLP the test substance does need to be classified for Eye Irritation Category 2. The test substance revealed slight effects on the cornea which were reversible within 10 days in 5/6 animals but persisted in 1/6 animals until day 21. Slight iridal effects were fully reversible by latest day 17. Chemosis was moderate and fully reversible within 21 days. Moderate conjunctival redness was observed but reversed within 14 days in 4/6 animals. Conjunctival redness grade 1 was still observed in 2/6 animals by day 21. However, redness scores ≤ grade 1 was not considered a positive finding in this study protocol. Using CLP criteria, serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision which is not fully reversible within 21 days of application. As hyperemia of some conjunctival blood vessels (i.e. redness grade 1) will not lead to a decay of vision and does also not represent tissue damage, the study protocol might be followed and redness (grade 1) observed in 2/6 animals on day 21 does not need to be considered for a classification for severe eye damage. However, due to the irreversibility of corneal opacity in 1/6 animals the study represents a borderline result between Eye Irritation Category 2 and Eye Damage Category 1.

A study assessing the irritating potential to the eyes with C12-13AE (CAS 66455-14-9) similar to OECD Guideline 405 was chosen to represent the higher carbon chain range of C10AE (Shell, 1979b). Three rabbits were treated with 0.2 mL test substance and observed for 7 days. The test substance revealed no effects on cornea, iris or conjunctivae. Thus, no classification is required for this test material.

In conclusion the weight of evidence shows that AE of a lower carbon chain length have a higher irritating potential to eyes compared to AE with a higher carbon chain length. For the lower carbon chain length (C6- C10) the mean 24, 48 and 72 h scores of both studies indicated that a classification for Eye Irritation Category 2 is required for AE of the lower carbon chain length. In total only 1/12 rabbits showed corneal opacity after 21 days. This single individual finding is considered to be not sufficient to conclude that the lower carbon chain lengths need to be classified for Eye Damage Category 1.

In absence of data decan-1-ol, ethoxylated (1-2.5 moles EO) (CAS 26183-52 -8) needs to be classified for Eye Irritation Category 2.

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 the substance does not need to be classified for skin irritation but needs to be classified for Eye Irritation Category 2.