Alcohols, C16-18 and C18-unsatd., ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 - 23 Oct 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1987

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2020

Deviations:

yes

Remarks:

no stepwise testing, no treatment with systemic analgesic/ topical anaesthesia of the animals / animal eyes; scoring according to Draize reported until reading time point 72 h only although effects were observed up to Day 7

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted in 1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-18 and C18-unsatd., ethoxylated

EC Number:

500-236-9

EC Name:

Alcohols, C16-18 and C18-unsatd., ethoxylated

Cas Number:

68920-66-1

Molecular formula:

not applicable, UVCB

IUPAC Name:

Alcohols, C16-18(even numbered) and C18 unsaturated, ethoxylated < 2.5 EO

Test animals / tissue source

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Breeding and Research Centre, Ejby, Lille Skensved, Denmark
- Weight at study initiation: 2.0 – 2.1 kg
- Housing: Individually, in PPO cages (floor area 2576 cm^2) with perflorated floor
- Diet: Altromin 2123 (Altromin, Lage, Germany), ad libitum
- Water: Drinking water acidified with hydrochloric acid (to pH 2.5), ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single administration without washing

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days after test item instillation

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: fluorescein and UV light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibiity not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

One hour after test item instillation, 2/3 rabbits showed diffuse redness (score 2) and 1/3 animals showed slight redness (score 1) of the conjunctiva. In addition, 2/3 animals showed an obvious swelling of the conjunctiva (score 2) while the third rabbit showed a slight swelling (score 1). Additionally, discharge with moistening of lids and hiars just adjacent to lids was observed in 2/3 animals.
At the 24 and 48 h readings, 2/3 animals showed diffuse redness (score 2) and obvious swelling (score 2) of the conjunctiva, while the last animal showed only slight redness (score 1) and swelling (score 1) of the conjunctiva.
72 h after administration of the test item, slight redness of the conjunctiva (score 1) was observed in all 3 rabbits, obvious swelling of the conjunctiva (score 2) was noted in 1/3 animals and slight swelling of the conjunctiva was observed in 2/3 animals.
At the day 7 reading, no signs of eye irritation were observed. However, the outer side of the lower lid in all 3 animals contained dried crusts with hairs, which could be removed from the lids.

Any other information on results incl. tables

Table 1: Eye irritation results

Rabbit	Corneal opacity			Iris			Conjunctival redness			Conjunctival chemosis			Conjunctival discharge
	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
1 h	0	0	0	0	0	0	2	2	1	1	2	2	0	2	2
24 h	0	0	0	0	0	0	2	2	1	2	2	1	0	0	0
48 h	0	0	0	0	0	0	2	2	1	2	2	1	0	0	0
72 h	0	0	0	0	0	0	1	1	1	2	1	1	0	0	0
Mean 24/48/72 h	0	0	0	0	0	0	1.67	1.67	1.00	2.00	1.67	1.00

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.