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:
1986-09-11 to 1986-09-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study not conducted according to GLP; however the study was conducted in a manner equivalent to relevant OECD guideline (405). The study contains a quality assurance statement and was conducted in accordance to the methodology proposed under the United States Federal Hazardous Substances Labelling Act (Federal Register, 1964, 29 13009).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Post-treatment observations were not performed at 14 and 21 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test report states that sample 758.05 is 47.5% sodium cocoyl isethionate in a soap bar. The substance was described as a waxy, white solid.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Age at study initiation: no data
- Weight at study initiation: >1.5kg
- Housing: Elevated wire mesh cages
- Diet (e.g. ad libitum): measured amount of Purina High Fiber Rabbit Chow (6oz/day) was offered to all rabbits rather than ad libitum feed.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >/= 7 days


ENVIRONMENTAL CONDITIONS

- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
- Temperature: 22-27 Degrees C
- Humidity: 56-79%


IN-LIFE DATES: From: 1986-09-11 To: 1986-09-25

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg
- Concentration (if solution): not applicable


VEHICLE
Not applicable
Duration of treatment / exposure:
Eyes were not flushed of test material, therefore the duration of exposure was 7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
not applicable - test substance was not flushed out of eyes


SCORING SYSTEM:
Draize technique

TOOL USED TO ASSESS SCORE: sodium fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
<= 34.2
Max. score:
34.2
Reversibility:
not specified
Remarks on result:
other: See table 1 below
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
<= 31
Max. score:
31
Reversibility:
not specified
Remarks on result:
other: See table 1 below
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
<= 28.8
Max. score:
28.8
Reversibility:
not specified
Remarks on result:
other: See table 1 below
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 4 days
Score:
<= 28
Max. score:
28
Reversibility:
not specified
Remarks on result:
other: See table 1 below
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 days
Score:
<= 20.3
Max. score:
20.3
Reversibility:
not specified
Remarks on result:
other: See table 1 below
Irritant / corrosive response data:
See table 1 below
Other effects:
None

Any other information on results incl. tables

Table 1: Average Eye Irritation Scores

Observation Period

Cornea

Iris

Conjunctivae

 

Opacity

Area

Redness

Chemosis

Discharge

Day 1

1.0

3.3

0.8

2.2

2.5

2.0

Day 2

1.0

2.8

0.8

2.5

2.7

1.2

Day 3

1.2

2.2

0.8

2.2

2.8

1.5

Day 4

1.3

1.8

0.7

2.0

2.3

1.3

Day 7

0.8

1.2

0.7

1.5

1.7

1.2

Table 2: Animal Body Weights

Animal Number

Sex

Vocalisation following dosing

Animal body weights (g)

Initiation

Day 7

Day 14

4736

M

N

2626

2860

2932

4737

M

N

2736

2862

2839

4738

M

N

2676

2636

2806

4776

F

N

2164

2432

2565

4740

F

N

2705

2886

3018

4741

F

N

2473

2668

2813

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the average scores for redness and chemosis, the substance showed irritating
properties under the conditions of this study.
Executive summary:

In this study, where 6 rabbits received a single application of 100 mg of the substance (47.5% pure), iris lesions and redness and chemosis of the conjunctivae were seen. Blanching of the conjunctivae was seen in all animals at Day 1, in two animals at Day 2, in three animals at Day 3, and one animal at Days 4 and 7. Corneal epithelial peeling was observed in all animals on Days 1 and 2, in five animals at Days 3 and 4, and in four animals at Day 7. Other signs observed in some animals included necrosis, pannus, and corneal neovascularisation. The average Draize score is determined to be 2.0, however for redness and chemosis of the conjunctivae the scores are higher. There was no pain response in any of the animals, no clinical signs were observed and all animals had healthy body weight gain.