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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 04, 1982 to May 18, 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to method equivalent to OECD Guideline 405, in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl carbamate
EC Number:
209-939-2
EC Name:
Methyl carbamate
Cas Number:
598-55-0
Molecular formula:
C2H5NO2
IUPAC Name:
methyl carbamate
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Douglassville, Pennsylvania
- Weight at study initiation: 2 - 3 Kg
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care andUse of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne rabbit ration, ad libitum
- Water: Fresh tap water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30 to 70%
- Photoperiod: 12 h dark and 12 h light

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST SUBSTANCE
- Amount(s) applied: 100 mg

VEHICLE
No vehicle
Duration of treatment / exposure:
14 d
Observation period (in vivo):
1, 24, 48, 72 h, 7 and 14 d after treatment
Number of animals or in vitro replicates:
3/sex/dose
Details on study design:
24 h prior to the application of the test substance, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing preexisting corneal injury were eliminated from the study. The test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball (conjunctival cul-de-sac) to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of substance. The contralateral eye remained untreated and served as a control.

SCORING SYSTEM:
An animal exhibited a positive reaction when the test substance produced one or more of the following signs:
- ulceration of the cornea (other than a fine stippling)
- opacity of the cornea (other than a slight dulling of the normal luster)
- inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels)
- an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids
- a diffuse crimson color with individual vessels not easily discernible

GRADING
Grading of irritation is according to the Draize's method.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
13.3
Max. score:
80
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of cornea score at 24, 48 and 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
20
Max. score:
80
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of cornea score at 24, 48 and 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
20
Max. score:
80
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Based on mean of cornea score at 24 ,48 and 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24-72 h
Score:
13.3
Max. score:
80
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of cornea score at 24, 48 and 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 24-72 h
Score:
13.3
Max. score:
80
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of cornea score at 24, 48 and 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 24-72 h
Score:
26.6
Max. score:
80
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Based on mean of cornea score at 24, 48 and 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
5
Max. score:
10
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of iris score at 24, 48 and 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
5
Max. score:
10
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of iris score at 24, 48 and 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
6.7
Max. score:
10
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Based on mean of iris score at 24, 48 and 72 h
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24-72 h
Score:
5
Max. score:
10
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of iris score at 24, 48 and 72 h
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 24-72 h
Score:
3.3
Max. score:
10
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of iris score at 24, 48 and 72 h
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 24-72 h
Score:
5
Max. score:
10
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of iris score at 24, 48 and 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
7.3
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of conjunctivae score at 24, 48 and 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48-72 h
Score:
10.7
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of conjunctivae score at 24, 48 and 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
12
Max. score:
20
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Based on mean of conjunctivae score at 24, 48 and 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24-72 h
Score:
6
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of conjunctivae score at 24, 48 and 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 7 d
Score:
8
Max. score:
20
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Based on mean of conjunctivae score at 24, 48 and 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24-72 h
Score:
7.3
Max. score:
20
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Based on mean of conjunctivae score at 24, 48 and 72 h
Irritant / corrosive response data:
At 1, 24 and 48 h after treatment: Positive ocular responses were observed in every rabbit.
At 72 h after treatment: Positive ocular responses were observed in 5 out of 6 rabbits.
On Day 7 after treatment: Positive ocular responses were observed in 2 out of 6 rabbits.
On Day 14 after treatment: No positive occular response was observed.

25 positive scores were recorded during the course of the study.

Any other information on results incl. tables

Table 1: Body weights at start and end of study

Animal number

Sex

Test substance

Initial weight (Kg)

Final weight (Kg)

1579

Male

1000 mg per eye

2.100

2.280

1580

Male

2.331

2.470

1581

Male

2.296

2.047

1582

Female

2.055

2.164

1583

Female

2.248

2.050

1584

Female

2.776

2.959

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In acute eye irritation test in rabbits, test substance was determined to be an eye irritant.
Executive summary:

A study was conducted to evaluate the irritant potential of the test substance on rabbit eye by a method equivalent to OECD Guideline 405, in compliance with GLP. 100 mg of undiluted test substance was administered in one of the eye of three males and three females. 24 h prior to administration, eyes were examined for any preexisting corneal injury using 2% sodium fluorescein stain. The test substance was placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the substance. The other eye, which remains untreated, serves as a control. The eyes were examined at 1, 24, 48 and 72 h and 7 and 14 d after treatment and ocular scoring was done according to Draize’s method. Positive ocular responses were observed in every rabbit at 1, 24, and 48 h after treatment. Positive ocular responses were also observed in five of six rabbits at 72 h after treatment. Two animals had positive ocular responses on Day 7. No positive scores were recorded on Day 14. Twenty-five positive scores were recorded during the study. Under the study conditions, test substance was determined to be an eye irritant (Mallory VT, 1982).