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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
Study period:
1983-09-02 - 1983-10-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

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:
2,2'-oxydi(ethylamine)
EC Number:
220-395-5
EC Name:
2,2'-oxydi(ethylamine)
Cas Number:
2752-17-2
Molecular formula:
C4H12N2O
IUPAC Name:
2-(2-aminoethoxy)ethan-1-amine
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-22-1, Order #J-170
- Substance type: clear liquid
- Physical state: liquid
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): Availability - fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries, Inc., Waterford, Wisconsin.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye remained untreated and served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
frequency and duration of administration: once
The upper and lower lids were then gently held together for one second to prevent loss of material.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours and 7, 10 and 13 days after treatment. The grades of ocular reaction were recorded at each examination.
Number of animals or in vitro replicates:
six animals (three males and three females)
Details on study design:
REMOVAL OF TEST SUBSTANCE: No data

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), or an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids and a diffuse crimson color with individual vessels not easily discernible. Grading of irritation is according to the method of Draize, J.H., et al., J. Pharm, Exp. Ther. 82: 377-390, (1944).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 13
Score:
98.4
Max. score:
110
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
7
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
11
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
11
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
12
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
8
Max. score:
12
Reversibility:
fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
12
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
5
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: see "Remarks"
Remarks:
beyond this time point, high degree of opacity prevented scoring of iris
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
10
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: see 'Remarks'
Remarks:
beyond this time point, high degree of opacity prevented scoring of iris
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
10
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: see 'Remarks'
Remarks:
beyond this time point, high degree of opacity prevented scoring of iris
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24 h
Score:
10
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: see 'Remarks'
Remarks:
beyond this time point, high degree of opacity prevented scoring of iris
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
10
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: see 'Remarks'
Remarks:
beyond this time point, high degree of opacity prevented scoring of iris
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
46
Max. score:
60
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
50
Max. score:
60
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
54
Max. score:
60
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
50
Max. score:
60
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
50
Max. score:
60
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
42
Max. score:
60
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
7
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
8
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
10
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
8
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
9
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
6
Max. score:
12
Reversibility:
not fully reversible within: 13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: see 'Remarks'
Remarks:
high degree of opacity prevented scoring of iris
Irritant / corrosive response data:
Positive ocular responses were observed at 1, 24, 48 and 72 hours and on Days 7, 10 and 13. Rupture of the globe, conjunctival necrosis and decreased body tone were observed during the course of the study.
Other effects:
One rabbit was found dead on Day 6 of the study. Necropsy revealed distended intestines filled with mucous and gelatinous material. The death was determined to be non-compound related (mucoid enteritis).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance was instilled in the right eye of six rabbits. Ocular readings were observed at 1, 24, 48 and 72 hours and 7, 10 and 13 days following administration of the test article. Positive ocular responses were recorded at 1, 24, 48 and 72 hours and on Days 7, 10 and 13. Rupture of the globe, conjunctival necrosis and decreased body tone were observed during the course of the study. The Draize score was observed to be 98.4. Based on the test results and the criteria of the CLP Regulation, the substance should be classified in category 1 (irreversible effects on the eye).