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:
From 2nd January 1985 to 22nd January 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No data on GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA guidelines 8/22/78 (40 CFR Part 163)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Test material: sodium chlorite 31% aqueous
Pale yellow liquid in white plastic bottle
Sample: T-1014 (32676)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Adult New Zeland albino rabbits, both sexes weights 2 kg.
-rabbit food and water ad libitum
-12 hour night-day lighting cycle
-relative humidity 40-50%
-temperature of animal room 20-25ºC
-indirect bedding of absorbent liners over pine shavings-stainless steel wire cages of USDA specifications-animal quarantine and acclimitization prior to dosing

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
The animals were clipped dorso-laterally from the pectoral to the pelvic areas. The test substance was moistened with water to form a paste and applied to the skin to cover no less than 10% of the body surface area.The treated skin was covered for 24 hours with a gauze dressing and a plastic over-wrap which were held to the skin under a rubberized sleeve.
Duration of exposure:
After 24 hours of semi-occlusive application, the animals were observed twice daily for signs of illness.
Doses:
1.67 ml (2.0 g of liquid) per kilogram bw
No. of animals per sex per dose:
10 animals per dose, both sexes
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths found
Body weight:
Average weight gain: +0.232 kg
Gross pathology:
Observations in all rabbits were normal except:-in 1 male rabbit: clear ascites in abdominal cavity. However, it is not believed to be due to the administration of the test material.-in 1 female rabbit: scattered petecchiae throughout all lobes of lung

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to CLP Regulation.
Conclusions:
The result was as follows:Dermal LD50 >2000 mg//kg bw (31% aqueous solution)
Executive summary:

The purpose of the study is to determine the topical (dermal) dose that is lethal to 50% of adult rabbits

The test was performed according to method EPA guideline 8/22/78 (40 CFR, Part 163).

10 adult New Zealand albino rabbits were used (both sexes, weights 2 kg).

The dose rate was 1.67 ml (2.0 g of liquid) bw.

After 24 hours of semi-occlusive application, the animals were observed twice daily for signs of illness.

The result was as follows:

Dermal LD50 >2000 mg//kg bw (31% aqueous solution)