Registration Dossier

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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Jeffcat DMP
Specific details on test material used for the study:
- Name of test material (as cited in study report): 5601-13-20
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-160
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Storage condition of test material: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglassville, Pennsylvania
- Age at study initiation: no data
- Weight at study initiation: 2.207-2.579 kg
- Housing: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
- Water (e.g. ad libitum):fresh tap water, fit for human consumption, ad libitum
- Acclimation period: 5 days


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


IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml



Duration of treatment / exposure:
1 second
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 (3♂ and 3♀)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: observation
-method of Draize, J. H. (1965): scale for scoring ocular lesions
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.


TOOL USED TO ASSESS SCORE: 2% sodium fluorescein stain

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1h
Score:
51.7
Max. score:
110
Remarks on result:
other: severely irritating
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
87
Max. score:
110
Remarks on result:
other: extermely irritating
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 and 72 hours
Score:
95
Max. score:
110
Remarks on result:
other: extremely irritating
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 days
Score:
91.7
Max. score:
110
Remarks on result:
other: extremely irritating
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 10 day
Score:
92
Max. score:
110
Remarks on result:
other: extremely irritating
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 13 day
Score:
79.5
Max. score:
110
Reversibility:
not fully reversible within: 13 days
Remarks on result:
other: severely irritating
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
5
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48 h
Score:
0
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48 h
Score:
5
Max. score:
10
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
5
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Score:
5
Max. score:
5
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
5
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48 h
Score:
0
Max. score:
5
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48 h
Score:
0
Max. score:
5
Reversibility:
not fully reversible within: 13 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
15
Max. score:
20
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
16
Max. score:
20
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
13
Max. score:
20
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48 h
Score:
19
Max. score:
20
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48 h
Score:
16
Max. score:
20
Reversibility:
not specified
Irritant / corrosive response data:
High degrees of opacity and excessive discharge were observed during the course of the study. Necrosis of the globe, rupture of the globe and keratoconus were also observed. Positive ocular responses were observed in every rabbit through all study.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Forty-two positive responses were recorded during the course of the study. (Draize Score = 95.0, extremely irritating). Based on the results and according to the criteria laid down in the CLP Regulation, the test substance is considered classified as causing serious eye damage category 1.