Sodium chlorate

Skin irritation / corrosion

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

Sodium chlorate

EC Number:

231-887-4

EC Name:

Sodium chlorate

Cas Number:

7775-09-9

Molecular formula:

ClHO3.Na

IUPAC Name:

sodium chlorate

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

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

Test system

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)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible

Results 2

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.

Any other information on results incl. tables

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	1	2	3	7	14
8903	Erythema/ eschar Oedema	0 0	0 0	0 0	0 0	- -	- -		0	0
8904	Erythema/ eschar Oedema	1 0	0 0	0 0	0 0	- -	- -		0	0
8905	Erythema/ eschar Oedema	0 0	0 0	0 0	0 0	- -	- -		0	0
8906	Erythema/ eschar Oedema	1 1	1 0	0 0	0 0	- -	- -		0.33	0
8907	Erythema/ eschar Oedema	0 0	1 0	0 0	0 0	- -	- -		0.33	0
8908	Erythema/ eschar Oedema	0 0	0 0	0 0	0 0	- -	- -		0	0
Mean Group									0.11	0

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

Applicant's summary and conclusion

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.