Fatty alcohols, C12-18 (even numbered), manuf. of, destn. residues

Endpoint summary

Description of key information

An OECD 404 primary skin irritation study was conducted with alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). No irritation was observed during the study and so the test item was concluded to be non-irritating to skin.
This result is used in a read-across approach in the REACH registration of alcohols, C12-18, distn. residues. 
An OECD 405 eye irritation study was conducted with alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). Signs of irritancy were clear by 72 hours. The test item was rated minimally irritating.
This result is used in a read-across approach in the REACH registration of alcohols, C12-18, distn. residues. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

from 2009-09-11 to 2009-10-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Read-across from analogue substance (Alcohols, C18-22, distn. residues). For details please refer to the read-across report.

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: Nichols Rabbitry Inc., Lumberton, TX, USA
- Age at study initiation: approx. 3 month
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: in suspended, wire-bottomed, stainless steel cages, 1 animal per cage
- Diet (e.g. ad libitum): Lab Rabbit Diet #5321 (PMI Feeds Inc.), approx. 8 oz. per day
- Water (e.g. ad libitum): Municipal water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 60 - 98
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2009-09-22 To: 2009-09-25

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mg


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after patch removal

Number of animals:

3 (2 male, 1 female)

Details on study design:

TEST SITE
- Area of exposure: 8 x 8 cm hair-free clipped area on the dorsal trunk
- % coverage: not mentioned
- Type of wrap if used: The test site was covered with a 4 ply, 2.5 x 2.5 cm surgical gauze patch, 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 (othopedic stockinette) wich was secured on both edges with strips of tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with room temperature tap water and a clean cloth to remove as much residual test substance as possible
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize, John H., Woodward, Geoffrey, and Calvery, H.O., Methods for the Study of Irriation and Toxicity of Substances Applied Topically to the Skin and Mucous Menbranes, J.Pham & Ther. 82, 377 (1944)

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

8

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0
- Edema: 0
REVERSIBILITY: not applicable

Other effects:

no other signs of skin irritation were recorded

Table #1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	0/0/0	0/0/0
24 h	0/0/0	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0
Reversibility*)	-	-
Average time (unit) for reversion	-	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Erythema and edema were not observed at any time throughout the study. No other signs of irritation were observed during the study. The primary irritation index of 0.0 of a possible 8.0 was obtained from the observations at 24, 48 and 72 hours, and was used to give the test substance Alcohols, C18-22, distn. residues (CAS BNo.: 1160164-88-4) a descriptive rating of non-irritant.
This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.

Executive summary:

A primary dermal irritation study was conducted in three albino rabbits using test substance Alcohols, C18 -22, distn. residues (CAS No: 1160164 -88-4). There was one intact test site per animal. Each test site was treated with 500 mg of test substance moistened with 0.1 mL of deionized water and covered with a semi-permeable dressing. The test substance was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48 and 72 hours after removal of the dressings. Erythema and edema were not observed at any time throughout the study. No other signs of irritation were observed during the study. Based on the Primary Irritation Index (PII) of 0.0, the test substance was rated non-irritating.

This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.

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:

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

Adequacy of study:

key study

Study period:

from 2009-09-11 to 2009-10-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Read-across from analogue substance (Alcohols, C18-22, distn. residues). For details please refer to the read-across report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Nichols Rabbitry Inc., Lumberton, TX, USA
- Age at study initiation: approx. 3 month
- Weight at study initiation: 2.70 - 3.15 kg
- Housing: in suspended, wire-bottomed, stainless steel cages, 1 animal per cage
- Diet (e.g. ad libitum): Lab Rabbit Diet #5321 (PMI Feeds Inc.), approx. 8 oz. per day
- Water (e.g. ad libitum): Municipal water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Humidity (%): 59 - 97
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2009-09-21 To: 2009-09-24

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as comparative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (33.1 mg)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours after test suubstance administration

Number of animals or in vitro replicates:

3 (females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): all treated eyes were washed out with room temperature deionized water for one minute
- Time after start of exposure: immediately after recording the 24-hour observation


SCORING SYSTEM:
according to Draize, John H., Woodward, Geoffrey, and Calvery, Herbert O., Journal of Pharmacol. Exp. Ther., 82, 377-390 (1944)


TOOL USED TO ASSESS SCORE: The treated eyes of all animals were examined without magnification under white room lighting provided by daylight-type fluorescent ceiling fixtures, and an additional source of white light affixed to the examination table or using a handheld flashlight.
After the 24-hour observation the corneas of all treated eyes were examined with a fluorescein sodium ophthalmic solution. A finoff ocular transilluminator with cobalt blue filter was utilized to enhance visualization of fluorescein staining.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0.44

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

see table below

Other effects:

none

Table #1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	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	1/0/1	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0.44	0
Area effected
Maximum average score (including area affected, max 110)
Reversibility*)	-	-	c.	-
Average time (unit) for reversion	-	-	72 h	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the maximum average irritation score of 2.0, obtained 1 hour after treatment, the test substance was rated minimally irritating. Fluorescein staining did not occur in any of the eyes.

Executive summary:

An acute eye irritation study was conducted on three albino rabbits using test substance Alcohols, C18 -22, distn. residues (CAS No: 1160164 -88 -4). The test substance, 0.1 mL by volume (33.1 mg) was placed into the conjunctival sac of the right eye of each animal selected for testing. All treated eyes were washed with room temperature deionized water for one minute immediately after recording the 24-hour observation. There were no positive effects exhibited in any eyes at any time after treatment. Non-positive irritation was clear by 72 hours, and the test substance was rated minimally irritating.

This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

SKIN: The skin irritancy potential ofalcohols, C18-22, distillation residues (CAS No. 1160164-88-4) was examined in a reliable (Klimisch 1) GLP compliant OECD 404 skin irritation/corrosion study with three albino rabbits. The test substance was maintained in contact with the skin for 4 hours. No erythema or oedema was observed at anytime throughout the study. The primary irritation index was 0.0 and so the test item in this study was non-irritating to the skin.

This result is used in a read-across approach in the REACH registration of alcohols, C12-18, distn. residues.

 

EYE: In a reliable (Klimisch 1) GLP compliant OECD 405 study the eye irritancy potential ofalcohols, C18-22, distillation residues (CAS No. 1160164-88-4) was assessed.The test substance, 0.1 mL by volume (33.1 mg) was placed into the conjunctival sac of the right eye of each animal selected for testing. All treated eyes were washed with room temperature deionized water for one minute immediately after recording the 24-hour observation. Signs of conjuctival irritation were clear by 72 hours, and the test substance was consequently rated minimally irritating to the eye. It should be noted that the extent of eye irritation was not sufficient to warrant classification under current EU regulations.

This result is used in a read-across approach in the REACH registration of alcohols, C12-18, distn. residues.

Justification for selection of skin irritation / corrosion endpoint:
No substances specific data are available for Alcohols, C12-18, distn. residues. Therefore, available data for the analogue substance Alcohols. C18-22, distn. residues are used. Details on the read-across justification are summarized in the attached read-across report.
An OECD 404 test (conducted under GLP) is available for the test substance (Alcohols. C18-22, distn. residues). During the study none of the animals did show signs of skin irritation. Therefore, it can be concluded that the substance not irritating.

Justification for selection of eye irritation endpoint:
No substances specific data are available for Alcohols, C12-18, distn. residues. Therefore, available data for the analogue substance Alcohols. C18-22, distn. residues are used. Details on the read-across justification are summarized in the attached read-across report.
An OECD 405 test (conducted under GLP) is available for the test substance (Alcohols. C18-22, distn. residues). There were no positive effects exhibited in any eyes at any time after treatment. Non-positive irritation was clear by 72 hours, and the test substance was rated minimally irritating. Therefore, it can be concluded that the substance not irritating.

Justification for classification or non-classification

These findings do not warrant the classification of alcohols, C18-22, distillation residues as skin or ocular irritants under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

This result is used in a read-across approach in the REACH registration of alcohols, C12-18, distn. residues.