Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1990 - January 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to standard US EPA protocol and under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
Principles other than OECD Guideline:
- limited reported study (not all details available)
- no initial and confirmatory test
- six rabbits
- observations untill day 14: reversibility is seen (21 days not necessary)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium Chlorate Crystal (Ercocide C)
- Physical state: white flake solid
- Analytical purity: 101.1% Sodium Chlorate Crystal
- Impurities (identity and concentrations): Chromium concentration = 2.1 ppm as Cr6
- Composition of test material, percentage of components: 101.1% Sodium Chlorate Crystal (Ercocide C)
- Purity test date: October 3, 1990 - October 11, 1990
- Lot/batch No.: Batch #DL-1 and further identified with PSL Code Number E01023-4
- Expiration date of the lot/batch: 9-1-91
- Stability under test conditions: Stable at ambient temperature
- Storage condition of test material: Cool and dry storage
- Other: pH 5.5; test substance received on October 23, 1990; 101.1% Sodium Chlorate Crytsral (Ercocide C) received from
the Sodium Chlorate Task Force.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ
- Age at study initiation: no info
- Weight at study initiation: no info
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad lib
- Water (e.g. ad libitum): no info
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: From: December 3, 1990 To: December 17, 1990

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of sieved test material (425 micron sieve)
- Concentration (if solution): 0.1 g


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
single application of 0,1 g test material into the left of right eye (other eye served as a control).
Observation period (in vivo):
At 1, 24, 48 and 72 hours and 4, 7, 10 and 14 days.
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing if done): not rinsed
- Time after start of exposure: not applicable


SCORING SYSTEM: Evaluated by the method of Draize (see table below) and further classified by the system of Kay and Calandra, Maximum Mean Total Score.


TOOL USED TO ASSESS SCORE: fluorescein to examine eyes before the test and incidentally to examine after the test

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 1/2/3 days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: After treatment no opacity is seen
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 1/2/3 days
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 1/2/3 days
Score:
1.56
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 1/2/3 days
Score:
0.72
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
No ulceration of corrosive effetcts were mentioned.
- Cornea: One hour post-instillation corneal opacity was noted in one treated eye. This was the only evidence seen for opacity.
- Iris: After 1, 24 and 48 hour(s) post-instillation iritis was observed in 2, 3 and 1 eye, respectively.
- Conjuntivae (Redness): Until 48 hours post-instillation conjunctival irritation was observed in all treated eyes.
- Conjuntivae (Chemosis): Up to 24 hr after dosing chemosis with partial eversion of the lids was observed in 3 animals in to other animals slight swelling was reported. All symptoms dissapeared 48 hours after exposure.
Other effects:
Localized injection of blood vessels was seen on days 4-7 in one rabbit. This was probably due to physical abrasion, possibly as a result of clawing.

Any other information on results incl. tables

Summary of ocular lesions

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean score iritis

Days 1/2/3

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

3

7

14

7914

Cornea

Iris

Redness

Chemosis

0

0

2

0

0

0

2

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0.33

7915

Cornea

Iris

Redness

Chemosis

0

0

2

1

0

1

2

1

0

1

2

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0.67

1.33

0.67

7916

Cornea

Iris

Redness

Chemosis

0

0

2

1

0

0

2

1

0

0

1

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0.67

7917

Cornea

Iris

Redness

Chemosis

0

0

3

2

0

1

3

2

0

0

2

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0.33

3

1

7918

Cornea

Iris

Redness

Chemosis

0

1

2

2

0

1

2

2

0

0

2

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0.33

1.67

1

7919

Cornea

Iris

Redness

Chemosis

1

1

2

2

0

0

2

2

0

0

1

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

1.33

0.67

Mean all anim.

0

0.22

1.56

0.72

* Nothing can be said about the area involved, because the author always scored 4 even if no effects are seen.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based on the results of the present study, it was concluded that the test compound induced a reversible slight eye irritation. Therefore, the substance is not classifiable according to OECD-GHS.
Executive summary:

A study was conducted to assess the irritancy potential of Sodium Chlorate Crystal to the eye of six New Zealand Albino rabbits. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Eye Irritation. The irritation score used is according to the recommendations by Draize (1959) and OECD Guideline 405 (Acute Eye Irritation/Corrosion). The study was designed and performed according to Good Laboratory Practice Standards.

A single application of 0.1 g of Sodium Chlorate Crystal to the left or the right eye of the rabbit produced moderate to severe redness of the conjunctivae. And all the treated conjunctivae showed moderate chemosis. Slight iritis was seen and no cornea-reaction occurred. Iris and conjunctivae effects are reversible within 7 days.

Based on the results of the present study, it was concluded that the test compound induced a reversible slight eye irritation. Therefore, the substance is not classifiable according to OECD-GHS.