Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 June 1991 - 07 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 81-2 (Acute Dermal Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Principles other than OECD Guideline:
- 24-h occlusive application
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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 temerature
- 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
Sex:
male/female
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: males 2.6-2.8 kg; females 2.5-2.8 kg
- 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
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: From: June 26, 1991 To: July 10, 1991

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: none, test substance applied moistened with water (0.3 ml per 1000mg)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10.2x5.08cm2 (4x2") (dorsal and ventral surfaces from scapular to pelvic area)
- % coverage: no info (10% clipped)
- Type of wrap if used: an adhesive-backed gauze patch containing test substance was placed on each rabbit. The patches and entire trunk of each rabbit were then wrapped with tape to aid in maintaining test patch position and to minimize evaporation. Neck collars were then placed on each rabbit.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24-h the patches and collars were removed and the exposed surface was gently wiped clean of any residual test substance.
- Time after start of exposure: 24-h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (completely moistened with distilled water)
- Concentration (if solution): not applicable (sample moistened with approximately 0.3 ml of distilled water per gram of test substance).
- Constant volume or concentration used: yes
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 ml per gram of test substance
- Concentration (if solution): not applicable
Duration of exposure:
24-h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed at 1, 2, and 4 h after dosing and once daily for the next 14 days. Body weight was measured at day 0, 7 and 14.
- Necropsy of survivors performed: yes, necropsy was performed on all survivors.
- Other examinations performed: clinical signs, body weight, histopathology.
Statistics:
No statistics.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
All the animals appeared healthy and active during the study period. Slight to moderate skin irritation was observed at the dose site for several days after dosing.
Body weight:
All animals gained weight over the 14-day observation period.
Gross pathology:
Gross necropsy findings were unremarkable. All tissues and organs appeared normal.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The Single Dose Acute Dermal LD50 of Sodium Chlorate Crystal, moistened with distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.
Executive summary:

Sodium Chlorate was evaluated for its acute dermal toxicity potential in albino rabbits. The study was performed in accordance with EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Dermal Toxicity. Similar to OECD Guideline 402 (Acute Dermal Toxicity). The study was designed and performed according to Good Laboratory Practice Standards.

For 24 hours 2000 mg/kg bw test substance (moistened with approximately 0.3 ml of distilled water per gram of test substance) is applied to the skin of ten albino rabbits. A single 24 -hour, occluded application of the test material to the intact skin produced a slight to moderate skin irritation. No mortality occurred. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour. All animals gained weight over the 14-day observation period. The gross necropsy showed that all tissues and organs appeared normal.

The Single Dose Acute Dermal LD50 of Sodium Chlorate Crystal, moistened with distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.