Alcohols, C16-18, ethoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 - 24 Nov 1986

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:

1986

Report date:

1986

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 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:

Hexadecan-1-ol

EC Number:

253-149-0

EC Name:

Hexadecan-1-ol

Cas Number:

36653-82-4

Molecular formula:

C16H34O

IUPAC Name:

hexadecan-1-ol

Constituent 2

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 3

Reference substance name:

2-[2-(Hexadecyloxy)ethoxy]ethanol

EC Number:

610-892-9

Cas Number:

5274-61-3

Molecular formula:

C20H42O3

IUPAC Name:

2-[2-(Hexadecyloxy)ethoxy]ethanol

Constituent 4

Reference substance name:

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

Cas Number:

4484-59-7

Molecular formula:

C22H46O

IUPAC Name:

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

Constituent 5

Reference substance name:

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

Cas Number:

5274-63-5

Molecular formula:

C24H50O5

IUPAC Name:

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

Constituent 6

Reference substance name:

Octadecan-1-ol

EC Number:

204-017-6

EC Name:

Octadecan-1-ol

Cas Number:

112-92-5

Molecular formula:

CH3(CH2)17OH

IUPAC Name:

octadecan-1-ol

Constituent 7

Reference substance name:

2-(octadecyloxy)ethanol

EC Number:

218-374-0

EC Name:

2-(octadecyloxy)ethanol

Cas Number:

2136-72-3

Molecular formula:

C20H42O2

IUPAC Name:

2-(octadecyloxy)ethanol

Constituent 8

Reference substance name:

2-[2-(Octadecyloxy)ethoxy]ethanol

EC Number:

605-213-8

Cas Number:

16057-43-5

Molecular formula:

C22H46O3

IUPAC Name:

2-[2-(Octadecyloxy)ethoxy]ethanol

Constituent 9

Reference substance name:

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

EC Number:

610-180-8

Cas Number:

4439-32-1

Molecular formula:

C24H50O

IUPAC Name:

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

Constituent 10

Reference substance name:

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

Cas Number:

59970-10-4

Molecular formula:

C26H54O5

IUPAC Name:

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

Constituent 11

Reference substance name:

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

Cas Number:

71093-13-5

Molecular formula:

C28H58O6

IUPAC Name:

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

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Remarks:

Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: Individually, in stainless steel cages
- Diet: K4 Alleindiät 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): With lukewarm physiological NaCl solution
- Time after start of exposure: 72 h after application

SCORING SYSTEM: Draize scoring system

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:

4

Reversibility:

other:

Remarks:

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:

Remarks:

Reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other:

Remarks:

Reversibility not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other:

Remarks:

Reversibility not applicable

Irritant / corrosive response data:

There were no eye irritation reactions observed for any animal during the 6 days observation period.

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.

Conclusions:

The test substance did not induce eye irritation in an in vivo study according to OECD guideline 405.