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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD 405. GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
5-ethyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
EC Number:
611-631-1
Cas Number:
58190-57-1
Molecular formula:
C11H23N3O3Si
IUPAC Name:
5-ethyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
Constituent 2
Reference substance name:
2-propanone, 2,2’,2’’-[O,O’,O’’-(ethylsilylidyne)trioxime]
IUPAC Name:
2-propanone, 2,2’,2’’-[O,O’,O’’-(ethylsilylidyne)trioxime]
Details on test material:
- Name of test material (as cited in study report): EAC3
- Physical state: Liquid
- Analytical purity: 92.13 %
- Lot/batch No.: 1000061820
- Expiration date of the lot/batch: 11 January 2013
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%), Protected from humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: ~13 weeks old (adult)
- Weight at study initiation: 3294 – 3525 g
- Housing: Individually in AAALAC approved metal wire rabbit cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 49 – 89 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3 male animals.
Details on study design:
OBSERVATIONS: The eyes were examined at 1, 24, 48 and 72 hours after treatment. Any clinical signs of toxicity or signs of ill-health during the study were recorded. Individual body weight was recorded at the beginning of the experiment and before euthanasia
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
other: mean 24-72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
other: mean 24-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
other: mean 24-72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: mean 24-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
other: mean 24-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
other: mean 24-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #1
Time point:
other: mean 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #2
Time point:
other: mean 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #3
Time point:
other: mean 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24-72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean 24-72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
Initial Pain Reaction (IPR) (score 2) was observed in all animals. One hour after the application: Conjunctival redness (score 1 or 2), conjunctival chemosis (score 1 or 2) and conjunctival discharge (score 2 or 3) were found in all animals. At 24 hours after the application: Conjunctival redness (score 1) was found in all animals. In addition conjunctival discharge (score 1) was noted in one animal. At 48 and 72 hours after the application no signs of eye irritation or other clinical signs were observed. As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation.

Any other information on results incl. tables

No mortality was observed.

The body weight and body weight change were considered to be normal with no indication of a treatment related effect.

There were no clinical signs observed that could be related to treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of 0.1 mL of EAC3 into one eye of each of three rabbits resulted in effects conjunctival redness (score 1) in all animals and conjunctival discharge (score 1) in one animal att 24 hours after the application. Based on these results, EAC3 was considered to be non irritant to the eye according to Regulation (EC) No 1272/2008.
Executive summary:

An acute eye irritation study of the test item EAC3 was performed in New Zealand White rabbits according to OECD Guideline 405 and GLP. 0.1 mL of the test item was placed as a single dose into the conjunctival sac of one eye of each animal (3 male rabbits). The untreated right eye served as control. Individual body weight was recorded at the beginning of the experiment and before euthanasia. Morbidity and clinical signs of toxicity were checked daily. No adverse effects were observed. The eyes were examined at 1, 24, 48 and 72 hours after the application. Initial Pain Reaction (IPR) (score 2) was observed in all animals. At 24 hours after the application conjunctival redness (score 1) was found in all animals and conjunctival discharge (score 1) was noted in one animal. The effects were fully reversible within 48 hours. Based on these results, EAC3 was considered to be non irritant to the eye according to Regulation (EC) No 1272/2008.