Registration Dossier

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: Guideline followed is similar to OECD 405 and was performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: According to the requirements of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicology Studies, 59 NohSan No. 4200.
Principles of method if other than guideline:
The guideline followed is similar to OECD guideline 405.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.68 - 3.16 kg
- Housing: housed individually in suspended metal cages.
- Diet: RABMA Rabbit Diet ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Humidity (%): 44 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 ml (instilled into the conjunctival sac of the right eye). The left eye was not treated and served as the control.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Prior to the start of the test, both eyes of each test animal were examined for evidence of ocular irritation or defect. Initially only one rabbit was treated with a volume of 0.1ml instilled into the conjunctival sac of the right eye. The left eye was untreated and served as the control. Immediately after administration, an assessment of the initial pain reaction was made. Upon this assessment, the remaining 5 test animals were treated with one drop of local anaesthetic (Ophthaine, 0.5% proxymetacaine hydrochloride) to minimise pain before instillation of the test material.

Assessment of ocular damage/irritation was made at 1, 24, 48 and 72 hours after treatment and evaluated according to the method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
4.8
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
110
Reversibility:
fully reversible

Any other information on results incl. tables

No corneal effects were observed during the study. Iridial inflammation was observed in one treated eye 1 hour after treatment, but no other iridial effects were noted. Minimal to moderate conjunctival irritation were observed in all treated eyes an hour after treatment. In one eye conjunctival redness persisted to the 24 -hour observation. All treated eyes appeared normal 24 -48 hours post-treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the eye irritation potential of ethyl methyl carbonate has been assessed and has been determined to not be irritating to the eyes.