Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
Sodium chlorite
EC Number:
231-836-6
EC Name:
Sodium chlorite
Cas Number:
7758-19-2
Molecular formula:
ClHO2.Na
IUPAC Name:
sodium chlorite
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 or test system 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
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)