Registration Dossier

Skin irritation/corrosion

Not a skin irritant (US EPA and equivalent to OECD guideline 404., GLP, K, rel. 1) based on the OECD-GHS.

Eye irritation

Not an eye irritant (US EPA and equivalent to OECD guideline 405., GLP, K, rel. 1) based on the OECD-GHS.

Respiratory irritation

No information.

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1991 - July 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to standard US EPA protocol and under GLP.

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Observations periods were only up to 72 hours

Principles of method if other than guideline:

Principles other than OECD Guideline:
- 4-h occlusive application
- 2 applications on 1 animal (intact and abraded skin)
- skin reactions were recorded up to 72 h after patch removal (no observations up to 14 days)
- 6 rabbits

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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): tap water, ad lib
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info

IN-LIFE DATES: From: June 26, 1991 To: June 29, 1991

Type of coverage:

occlusive

Preparation of test site:

other: clipped + abraded

Vehicle:

other: none, applied as received undiluted, moistened with 0.2 mL water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g undiluted test substance moistened with 0.2 ml of distilled water
- Concentration (if solution): not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): not apllicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable

Duration of treatment / exposure:

4 hours

Observation period:

After patch removal: 1, 24, 48 and 72 hours

Number of animals:

6 (3 males and 3 females): each with 2 test sites (intact and abraded) and 2 untreated control sites (intact and abraded)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm2 (2 test application sites -abraded and intact- and 2 untreated control sites)
- % coverage: clipped skin is 10% of the body surface
- Type of wrap if used: adhesive backed-gauze patches secured in place with tape wrapping

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently wiped clean of any residual test substance
- Time after start of exposure: after 4 hours patches were removed

SCORING SYSTEM: Draize scoring system (Primary Dermal Irriation Scores) (see below)

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The incidence and severity of irritation generally decreased by 24 hours. By 72 hours all sites (intact and abraded) were free of irritation. No irritation was noted at any of the control sites during the study.

Summary of dermal lesions on clipped (intact) skin (following 4-h application).

Remark: Erythema and oedema skin effects on abraded skin were slightly more severe compared with those on unabraded skin.

no.

Effect

Hour

Days after application

Mean score erythema

24/48/72 h *

Mean score oedema

24/48/72 h *

1

2

3

7

14

8903

Erythema/ eschar

Oedema

0

-

0

8904

Erythema/ eschar

Oedema

1

0

-

0

8905

Erythema/ eschar

Oedema

0

-

0

8906

Erythema/ eschar

Oedema

1

0

-

0.33

0

8907

Erythema/ eschar

Oedema

0

1

0

-

0.33

0

8908

Erythema/ eschar

Oedema

0

-

0

Mean Group

0.11

0

* Mean score based on 24, 48 and 72 h after application

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.

Executive summary:

A primary dermal irritation study was conducted on six albino rabbits using test substance Sodium Chlorate Crystal. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Skin Irritation. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.

Each animal had 2 test sites (clipped and abraded) and 2 untreated control sites (clipped and abraded). On each test site 0.5 g test material moistened with 0.2 ml of distilled water was applied. A single 4 -hour, occluded application of the test material to the intact skin produced immediately after patch removal none to very slight erythema and oedema. By 48 hours these test sites were free of irritation again and the observations were only up to 72 hours. Necrosis and ulceration were not reported.

Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

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.

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Liimited reported study (not all details available) / no initial and confirmatory test / six rabbits / observations untill day 14: reversibility is seen (21 days not necessary)

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

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

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

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

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:

24/48/72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible within: 3 days

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.56

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

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.

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

2

3

7

14

7914

Cornea

Iris

Redness

Chemosis

0

2

0

2

1

0

1

0

1

0.33

7915

Cornea

Iris

Redness

Chemosis

0

2

1

0

1

2

1

0

1

2

1

0

0.67

1.33

0.67

7916

Cornea

Iris

Redness

Chemosis

0

2

1

0

2

1

0

1

0

1

0.67

7917

Cornea

Iris

Redness

Chemosis

0

3

2

0

1

3

2

0

2

1

0

1

0

0.33

3

1

7918

Cornea

Iris

Redness

Chemosis

0

1

2

0

1

2

0

2

1

0

1

0

0.33

1.67

1

7919

Cornea

Iris

Redness

Chemosis

1

2

0

2

0

1

0

1

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.

Interpretation of results:

GHS criteria not met

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.

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no adverse effect observed (not irritating)

Skin irritation/corrosion:

A key study was identified (Shapiro, PSL, 1991, rel. 1, K).

A primary dermal irritation study was conducted on six albino rabbits using test substance Sodium Chlorate Crystal. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Skin Irritation. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.

Each animal had 2 test sites (clipped and abraded) and 2 untreated control sites (clipped and abraded). On each test site 0.5 g test material moistened with 0.2 ml of distilled water was applied. A single 4 -hour, occluded application of the test material to the intact skin produced immediately after patch removal none to very slight erythema and oedema. By 48 hours these test sites were free of irritation again and the observations were only up to 72 hours. Necrosis and ulceration were not reported.

Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.

Eye irritation:

A key study was identified (Shapiro, PSL, 1991, rel. 1, K).

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.

Harmonised classification:

The substance has an harmonized classification according to the Regulation (EC) No. 1272/2008 and to the GHS.

Self classification:

Skin irritation:

Based on the available data, the test item is not classified for skin irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and the GHS.

Eye irritation:

Based on the available data, the test item is not classified for eye irritation according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Respiratory irritation:

No data was available regarding respiratory irritation.