Alcohols, C12-14, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

24 - 30 May 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1981

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 approach; no treatment with systemic analgesic or topical anaesthesia of the animals / animal eyes prior, during or after test substance application

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecan-1-ol

EC Number:

203-982-0

EC Name:

Dodecan-1-ol

Cas Number:

112-53-8

Molecular formula:

C12H26O

IUPAC Name:

Dodecan-1-ol

Constituent 2

Reference substance name:

2-(dodecyloxy)ethanol

EC Number:

224-886-5

EC Name:

2-(dodecyloxy)ethanol

Cas Number:

4536-30-5

Molecular formula:

C14H30O2

IUPAC Name:

2-(dodecyloxy)ethanol

Constituent 3

Reference substance name:

2-[2-(dodecyloxy)ethoxy]ethanol

EC Number:

221-279-7

EC Name:

2-[2-(dodecyloxy)ethoxy]ethanol

Cas Number:

3055-93-4

Molecular formula:

C16H34O3

IUPAC Name:

2-[2-(dodecyloxy)ethoxy]ethanol

Constituent 4

Reference substance name:

2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethanol

EC Number:

221-280-2

EC Name:

2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethanol

Cas Number:

3055-94-5

Molecular formula:

C18H38O4

IUPAC Name:

2-{2-[2-(dodecyloxy)ethoxy]ethoxy}ethanol

Constituent 5

Reference substance name:

3,6,9,12-tetraoxatetracosan-1-ol

EC Number:

226-097-1

EC Name:

3,6,9,12-tetraoxatetracosan-1-ol

Cas Number:

5274-68-0

Molecular formula:

C20H42O5

IUPAC Name:

3,6,9,12-tetraoxatetracosan-1-ol

Constituent 6

Reference substance name:

3,6,9,12,15-pentaoxaheptacosan-1-ol

EC Number:

221-281-8

EC Name:

3,6,9,12,15-pentaoxaheptacosan-1-ol

Cas Number:

3055-95-6

Molecular formula:

C22H46O6

IUPAC Name:

2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol

Constituent 7

Reference substance name:

3,6,9,12,15,18-hexaoxatriacontan-1-ol

EC Number:

221-282-3

EC Name:

3,6,9,12,15,18-hexaoxatriacontan-1-ol

Cas Number:

3055-96-7

Molecular formula:

C24H50O7

IUPAC Name:

2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethanol

Constituent 8

Reference substance name:

3,6,9,12,15,18,21-heptaoxatritriacontanol

EC Number:

221-283-9

EC Name:

3,6,9,12,15,18,21-heptaoxatritriacontanol

Cas Number:

3055-97-8

Molecular formula:

C26H54O8

IUPAC Name:

2-[2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethanol

Constituent 9

Reference substance name:

Tetradecanol

EC Number:

204-000-3

EC Name:

Tetradecanol

Cas Number:

112-72-1

Molecular formula:

C14H30O

IUPAC Name:

tetradecan-1-ol

Constituent 10

Reference substance name:

2-(tetradecyloxy)ethanol

EC Number:

218-371-4

EC Name:

2-(tetradecyloxy)ethanol

Cas Number:

2136-70-1

Molecular formula:

C16H34O2

IUPAC Name:

2-(tetradecyloxy)ethanol

Constituent 11

Reference substance name:

2-(2-Tetradecyloxyethoxy)ethanol

EC Number:

611-348-3

Cas Number:

56049-79-7

Molecular formula:

C18H38O3

IUPAC Name:

2-(2-Tetradecyloxyethoxy)ethanol

Constituent 12

Reference substance name:

2-[2-[2-(tetradecyloxy)ethoxy]ethoxy]ethanol

EC Number:

248-016-9

EC Name:

2-[2-[2-(tetradecyloxy)ethoxy]ethoxy]ethanol

Cas Number:

26826-30-2

Molecular formula:

C20H42O4

IUPAC Name:

2-{2-[2-(tetradecyloxy)ethoxy]ethoxy}ethanol

Constituent 13

Reference substance name:

2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethanol

Cas Number:

39034-24-7

Molecular formula:

C22H46O5

IUPAC Name:

2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethanol

Constituent 14

Reference substance name:

2-[2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol

Cas Number:

92669-01-7

Molecular formula:

C24H50O6

IUPAC Name:

2-[2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol

Constituent 15

Reference substance name:

Hexadecan-1-ol

EC Number:

253-149-0

EC Name:

Hexadecan-1-ol

Cas Number:

36653-82-4

Molecular formula:

C16H34O1

IUPAC Name:

Hexadecan-1-ol

Constituent 16

Reference substance name:

2-(hexadecyloxy)ethanol

EC Number:

218-373-5

EC Name:

2-(hexadecyloxy)ethanol

Cas Number:

2136-71-2

Molecular formula:

C18H38O2

IUPAC Name:

2-(hexadecyloxy)ethanol

Constituent 17

Reference substance name:

Unknown constituents

IUPAC Name:

Unknown constituents

Test material form:

liquid

Details on test material:

Density: ca. 0.9 mg/cm³

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Remarks:

Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Kar1 Thomae GmbH, Biberach, Germany
- Weight at study initiation: 1.7 - 2.0 kg
- Housing: Individual housing in stainless steel cages
- Diet: K4 Alleindiat für Kaninchen (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

72 h

Observation period (in vivo):

6 days
Reading time points: 1, 24, 48 and 72 h and 6 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm physiological saline solution
- Time after start of exposure: 72 h

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

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:

0

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:

0

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

One hour after test item instillation, conjunctival redness was observed in all 3 animals. The finding persisted in 2/3 rabbits up to 24 h post administration and in 1/3 rabbits up to 48 h after instillation. Thereafter, the animals did no longer show any eye irritation effects. Corneal opacity, irits or conjunctival chemosis findings were not observed at any reading time point.

Any other information on results incl. tables

Table 1: Eye irritation results

Rabbit	Corneal opacity			Iris			Conjunctival redness			Conjunctival chemosis
	1	2	3	1	2	3	1	2	3	1	2	3
1 h	0	0	0	1	1	1	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	0	0	0	0
72 h	0	0	0	0	0	0	0	0	0	0	0	0
6 days	0	0	0	0	0	0	0	0	0	0	0	0
Mean 24/48/72 h	0.00	0.00	0.00	0.00	0.00	0.00	0.67	0.00	0.33	0.00	0.00	0.00

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.