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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Qualifier:
equivalent or similar to
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

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

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

Resultsopen allclose all
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.

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
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
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.