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

Eye irritation

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1160164-88-4

Cas Number:

1160164-88-4

IUPAC Name:

1160164-88-4

Constituent 2

Reference substance name:

Alcohols, C18-22, distn. residues

IUPAC Name:

Alcohols, C18-22, distn. residues

Details on test material:

- Name of test material (as cited in study report): Alcohols C18-22, distn. residues
- Substance type: pure active substance
- Physical state: solid
- Storage condition of test material: at room temperature

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Results 3

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

Results 4

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

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.