2,2'-Oxydiethanol, propoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-Oxydiethanol, propoxylated

EC Number:

500-031-4

EC Name:

2,2'-Oxydiethanol, propoxylated

Cas Number:

9051-51-8

Molecular formula:

C4 H10 O3 (C3 H6 O) n, where n average >1 and n<4.5

IUPAC Name:

2,2'-Oxydiethanol, propoxylated

Details on test material:

Name of test item: DEG+3PO
Test item No.: 09/0470-1
Batch identification: T35/039/09
CAS No.: 9051-51-8
Purity: 100%
Appearance: Colourless clear liquid
Homogeneity: The test item is homogeneous by visual inspection.
Conditions of storage: Ambient (RT), hygroscopic
Storage stability: The stability of the test item is guaranteed throughout the study period.
pH-value: 7.2 (1% solution in deionized water, w/w).

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 - 36, 88353 Kisslegg
- Age at study initiation: Ca. 9 weeks
- Weight at study initiation: 2.2 kg - 2.6 kg
- Housing: Terulan cages, Ehret GmbH, A-3430 Tulin, 65 cm x 65 cm bottom area, 50 cm height.; Wooden gnawing blocks (Typ KNH E-041); Abedd ® Lab. and Vet. Service GmbH Vienna, Austria; Single housing
- Diet: Ssniff K-H maintenance diet for rabbits (item V-2333-000), ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany. Analysis of the feed for ingredients and contaminants is performed randomly by Ssniff. Hay-briquettes (from the same source as the feed) are offered additionally as a dietary supplement.
- Water: Tap water from an automatic watering system ad libitum
- Acclimation period: For at least 5 days before application.

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 30-70%
- Air changes (per hr): 12
- 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:

single dose

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

Body weight determination: Just before application of the test item and after the last reading.
Route of application: The test item was applied in a single dose to the conjunctival sac of the right eyelid.
Application volume: 0.1 mL
Negative control: Untreated left eye
Readings: Approx. 1, 24, 48 and 72 h after application.
Illumination used for reading: The eyes were examined using an otoscope lamp.
Mortality: A check for any dead or moribund animal was made twice each workday (at the beginning and end of work) and once daily at weekends and on public holidays.

Assessment of ocular reactions: The evaluation of eye irritation was performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24,48 and 72 hours

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. No ocular reactions were observed in all animals at any examination term.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.0, 0.0 and 0.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Considering the described ocular reactions as well as the average score for irritation, "DEG+3PO" is not irritating to eyes under the conditions of this test.