Alcohols, C13-15

Endpoint summary

Description of key information

Skin Irritation:

Alcohols, C13-C15 causes moderate irritation to rabbit skin.

Hence, Alcohols, C13-C15 can be considered to be irritating to skin.

Eye Irritation:

Alcohols, C13-C15 did not cause any severe reactions to rabbit eyes.

Hence, Alcohols, C13-C15 can be considered to be not 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:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/EEC, B.4 "Acute toxicity (skin irritation)"

Principles of method if other than guideline:

The dermal irritation potential of Alcohols, C13-C15 was evaluated in rabbits following the method prescribed in Directive 84/449/EEC, B.4 "Acute toxicity (skin irritation)"

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material: Alcohols, C13-15
- IUPAC name: Alcohols, C13-15
- Molecular formula: C13H280 + C15H32O
- Molecular weight: 208.78 g/mole
- Substance type: Organic
- Physical state: Liquid

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data available

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

No data available

Duration of treatment / exposure:

No data available

Observation period:

No data available

Number of animals:

No data available

Details on study design:

No data available

Other effects / acceptance of results:

No data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: No data available

Reversibility:

not specified

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

Moderate irritation observed

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Alcohols, C13-C15 causes moderate irritation to rabbit skin.
Hence, Alcohols, C13-C15 can be considered to be irritating to skin.

Executive summary:

The dermal irritation potential of Alcohols, C13-C15 was evaluated in rabbits following the method prescribed in Directive 84/449/EEC, B.4 "Acute toxicity (skin irritation)".

Alcohols, C13-C15 was applied to the skin of rabbits and observed for signs of irritation (dose, duration and observation period not mentioned).

Alcohols, C13-C15 causes moderate irritation to rabbit skin.

Hence, Alcohols, C13-C15 can be considered to be irritating to skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment reports

Qualifier:

according to guideline

Guideline:

other: Directive 84/449/EEC, B.5 "Acute toxicity (eye irritation)"

Principles of method if other than guideline:

The ocular irritation potential of Alcohols, C13-C15 was evaluated in rabbits following the method prescribed in Directive 84/449/EEC, B.5 "Acute toxicity (eye irritation)"

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material: Alcohols, C13-15
- IUPAC name: Alcohols, C13-15
- Molecular formula: C13H280 + C15H32O
- Molecular weight: 208.78 g/mole
- Substance type: Organic
- Physical state: Liquid

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

No data available

Duration of treatment / exposure:

No data available

Observation period (in vivo):

No data available

Duration of post- treatment incubation (in vitro):

No data available

Number of animals or in vitro replicates:

No data available

Details on study design:

No data available

Other effects / acceptance of results:

No data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: No data available

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritation observed

Interpretation of results:

other: not irritating

Conclusions:

Alcohols, C13-C15 did not cause any severe reactions to rabbit eyes.
Hence, Alcohols, C13-C15 can be considered to be not irritating to eyes.

Executive summary:

The ocular irritation potential of Alcohols, C13-C15 was evaluated in rabbits following the method prescribed in Directive 84/449/EEC, B.5 "Acute toxicity (eye irritation)".

Alcohols, C13-C15was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration and observation period not mentioned).

Alcohols, C13-C15 did not cause any severe reactions to rabbit eyes.

Hence, Alcohols, C13-C15 can be considered to be not irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

Several studies were performed to ascertain the degree of dermal irritation caused by Alcohols, C13-15in living organisms. These studies include in vivo studies in rabbits as well as predicted data for the target chemical as well its structurally similar read across chemicals, Tridecanol [CAS: 112-70-9] and Undecan-1-ol [CAS: 112-42-5].Thepredicted data using the OECD QSAR toolbox has also been compared with the experimental data.

The dermal irritation potential of Alcohols, C13-C15 was evaluated (IUCLID Dataset, EUROPEAN COMMISSION – European Chemicals Bureau, 2000) in rabbits following the method

prescribed in Directive 84/449/EEC, B.4 "Acute toxicity (skin irritation)".

Alcohols, C13-C15 was applied to the skin of rabbits and observed for signs of irritation (dose, duration and observation period not mentioned).

Alcohols, C13-C15 causes moderate irritation to rabbit skin.

Hence, Alcohols, C13-C15 can be considered to be irritating to skin.

In a prediction done by SSS (2018) using the OECD QSAR toolbox v3.4 with log kow as the primary descriptor, the dermal irritation potential was estimated forAlcohols, C13-15. Alcohols, C13-15was irritating to New Zealand White rabbit skin.

 

 

The results of the experimental and estimated data are in agreement with each other indication a possibility of Alcohols, C13-15 being irritating to skin.

These results are supported by the experimental study performed by R. A. SCALA & E. G. BURTIS (American Industrial Hygiene Association Journal, (1973), 34:11, 493-499) on clipped and intact abdominal skin of albino rabbits to assess the dermal irritation potential of the structurally similar read across chemical, Tridecanol [CAS: 112-70-9]. Tridecanol was applied full-strength to the closely clipped, intact abdominal skin of albino rabbits in groups of four. The exposed area was covered with an occlusive binding of dental damming for 24 hours. After the exposure, the binding was removed, and the remaining material, if any, was cleaned from the skin. The animals were housed individually with feed and water freely available. No mechanical restraints were used. Observations for dermal irritation were made on a daily basis. Gross necropsies were performed at the end of the experiments. Grading scale was slight-moderate-marked and severe.

The findings reveled persistent atonia and desquamation with some necrosis or eschar. Part of the irritation seen was associated with trapping of liquid under the occlusive binder at a point where the binder was bound to the animal. These areas of intimate contact and pressure gave rise to some of the reported necrosis and eschar. Also the chemical showed good dose relations for intensity and duration.

Therefore, Tridecanol (CAS no: 112-70-9) was considered as moderately irritating to the clipped and intact abdominal skin of albino rabbits.

The above results are further supported by the experimental studyperformed by G. Klecak et.al [Journal of the Society of Cosmetic Chemists, Vol. 28, No. 2, 53-64; 1977] on Himalayan white-spotted guinea pigs (male and female) to determine the irritation potential of the structurally similar read across chemical, Undecan-1-ol[CAS: 112-42-5]. 0.025ml of chemical was applied to an area measuring 2cm2previously marked with a circular stamp on the clipped flanks of 6- 8 Himalayan white-spotted guinea pigs under non-occlusive conditions. Skin reactions were evaluated after 24 hours of application. The chemical caused mild erythema in at least 25 percent of the animals of the group concerned at concentration of 3%.

Therefore, the chemical Undecan-1-ol (CAS No: CAS no: 112-42-5) was considered as irritating to the skin of Himalayan white-spotted guinea pigs.

 

Based on the available data for the target chemical as well as its structurally similar read acrosschemicals, Alcohols, C13-15 is likely to cause moderate skin irritation. Alcohols, C13 -15 can be considered to be irritating to skin and classified under the category “Category 2” as per CLP criteria.

Eye Irritation:

Several studies were performed to ascertain the degree of ocular irritation caused by Alcohols, C13-15in living organisms. These studies include in vivo studies in rabbits as well as predicted data for the target chemical as well its structurally similar read across chemicals, Cetyl alcohol[CAS: 36653-82-4] and Octyl Dodecanol[CAS: 5333-42-6]. Thepredicted data using the OECD QSAR toolbox has also been compared with the experimental data.

The ocular irritation potential of Alcohols, C13-C15 was evaluated (IUCLID Dataset, EUROPEAN COMMISSION – European Chemicals Bureau, 2000) in rabbits following the method prescribed in Directive 84/449/EEC, B.5 "Acute toxicity (eye irritation)".

Alcohols, C13-C15 was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration and observation period not mentioned). Alcohols, C13-C15 did not cause any severe reactions to rabbit eyes.

Hence, Alcohols, C13-C15 can be considered to be not irritating to eyes.

In a prediction done by SSS (2018) using the OECD QSAR toolbox v3.4 with log kow as the primary descriptor, the eye irritation potential was estimated forAlcohols, C13-15. Alcohols, C13-15was not irritating to New Zealand White rabbit eyes.

 

The results of the experimental and estimated data are in agreement with each other indication a possibility of Alcohols, C13-15 being not irritating to eyes.

These results are further supported by the experimental study summarized in JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Volume 7, Number 3, 1988, pg 359-413; for the structurally similar read across chemical, cetyl alcohol[CAS: 36653-82-4]. The study was performed by the modification of the Draize test procedure.

0.1 ml undiluted (100%) cetyl alcohol was instilled in the conjunctival sac of 6 male and female New Zealand albino rabbits. The eyes were observed and scored according the method of Draize at days 1, 2, 3, 4 and 7 post- instillation. The minimum score = 0 and maximum score = 110.

An average score of 1 was reported on day 1, and signs of irritation had cleared by day 2. Cetyl alcohol was practically nonirritating.

Hence, cetyl alcohol can be considered to be not irritating to rabbit eyes.

The above results are also supported by the experimental study summarized in JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Volume 4, no. 5 (1985): 1-29; for the structurally similar read across chemical, Octyl Dodecanol[CAS: 5333-42-6]. 100 percent undiluted Octyl Dodecanol was instilled into the eyes of 6 rabbits and observed for signs of irritation.

The rabbits were observed and scored from day 1 till day 4. The minimum and maximum attainable scores were 0 and 110. The average irritation score of 4 (max, 110) on Day 1,decreased to a score of 0 by Day 4.

Since the effects were fully reversible in 4 days, Octyl Dodecanol can be considered to be not irritating to rabbit eyes.

Based on the available data for the target chemical as well as its structurally similar read across chemicals, Alcohols, C13-15 is not likely to cause any eye irritation. Alcohols, C13-15 can be considered to be not irritating to eyes in and classified under the category “Not Classified” as per CLP criteria. 

Justification for classification or non-classification

Available data for Alcohols, C13-15 indicates that it is not likely to cause severe irritation or corrosion to eyes, but causes slight to moderate irritation to skin.

Hence, Alcohols, C13-15 can be classified under the category “Not Classified” for eye irritation and “Category 2” for skin irritation as per CLP regulation.