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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:
key study
Study period:
10 October 1983 to 17 October 1983
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon biomedical sciences Inc.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton dutchland inc. Denver PA
- Age at study initiation: Approximately 22 weeks
- Weight at study initiation: 2.84 to 3.37 kg
- Housing: Individual, steel housing
- Diet (e.g. ad libitum): Purina rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 70 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 1 August 1983 To: 17 October 1983

Test system

Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Assumed 100%
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
1, 4, 24, 48, 72 hours, 4, 7 days
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 4 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
6
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 4 h
Score:
2
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 4 h
Score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 4 h
Score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 4 h
Score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 4 h
Score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 4 d
Score:
1
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 4 h
Score:
1
Reversibility:
fully reversible within: 24 hr
Irritant / corrosive response data:
Conjunctival irritation consisting of redness ranging from some vessels definitely injected to diffuse, cimson red. Individual vessels not easily discernible was observed in the treated eyes of all animals during the 1 and 4 hour observations. Corneal ulceration was noted and confirmed using fluorescein stain in one animal at the 24 hour observation. The eyes of all rabbits were clear of any signs of irritation by day 7 and the study was terminated.

The total draize score during the study ranged from 0 to 6.
Other effects:
There were no animal deaths noted prior to study termination.

Any other information on results incl. tables

Results tables can be found in the attachment to this RSS.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
Conjunctival irritation consisting of redness ranging from some vessels definitely injected to diffuse, cimson red. Individual vessels not easily discernible was observed in the treated eyes of all animals during the 1 and 4 hour observations. Corneal ulceration was noted and confirmed using fluorescein stain in one animal at the 24 hour observation. The eyes of all rabbits were clear of any signs of irritation by day 7 and the study was terminated.

The total draize score during the study ranged from 0 to 6.
Executive summary:

The ocular irritation potential of MRD-83-306 was evaluated following a single 0.1 ml instillation to the right eye of 6 rabbits. The treated eyes of all animals remained unwashed. Observations for signs of ocular irritation and toxicity were made as 1, 4, 24, 48 and 72 hours post-instillation and once per day on days 4 and 7. Ocular reactions were graded according to the Draize scale for scoring ocular lesions. Body weights were recorded on the day of dosing. After day 7 observations all animals were euthanised with an IV injection of T-61.

 

Ocular exposure to MRD-83-306 resulted in conjunctival irritation consisting of redness. Individual vessels not easily discernible in all animals at the 1 and 4 hour observations. Corneal ulceration was noted and confirmed using fluorescein stain at the 24 hour observation. All animals were clear of any signs of irritation by day 7.