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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
0
Max. score:
3
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.