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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with the Health Effects Test Guidelines, U.S. Environmental Protection Agency Office of Pesticides and Toxic Substances (August 1982) and was performed in compliance with the conditions of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Guideline:
other: EPA Guideline
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
EC Number:
239-707-6
EC Name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
Cas Number:
15630-89-4
Molecular formula:
CH2O3.3/2H2O2.2Na
IUPAC Name:
tetrasodium tris(peroxol) dicarbonate
Details on test material:
moistened with saline

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young adult female and male rabbits, Hra:(NZW)SPF, were procured, maintained individually in screen-bottom cages in temperature and humidity-controlled quarters, provided access to water ad libitum and a measured amount of High Fiber Rabbits Chow 5326, Purina Mills, Inc., and held for an acclimation period of at least 7 days. Five male and five female rabbits acclimated rabbits, weighing from 2510 to 2894 g, were chosen at random, treated, and maintained during the observation period as specified for the acclimation period.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: An area making up approximately 20 % of the total body surface area was shaved with an electronic clipper 24 hours before the test.
- % coverage: The area of application was covered with a 10 x 10 cm gauze patch secured with paper tape.
- Type of wrap if used: Saran wrap and Elastoplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 24 hours after exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bodyweight based upon each animal's bodyweight at study initiation
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after administration. Thirty minutes after removal of the test material the initial dermal irritation reading was made. Subsequent readings of dermal irritation were done on days 3, 7, 10 and 14. The animals were observed daily for clinical signs and twice per day for mortality. The animals were weighed prior to test material application, at day 7 and at termination of the experiment.
- Necropsy of survivors performed: yes
Statistics:
No statistical method was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
other: No clinical signs related to the test material were observed.
Gross pathology:
Severe dermal irritation consisting of slight to severe erythema and edema, and slight to marked atonai, desquamation, coriaceousness, and fissuring. Other dermal effects included subcutaneous hemorrhaging, blanching, possible necrotic areas, eschar, exfoliation, and possible scar tissue.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was not acutely toxic via the dermal route and the LD50 value was greater than 2000 mg/kg bodyweight.
Executive summary:

The acute dermal toxicity of sodium percarbonate was evaluated in male and female rabbits according to the relevant guideline of the US EPA Office of Pesticides and Toxic Substances (August 1982) and following the conditions of GLP. Dermal toxicity was tested at a level of 2.0 g/kg bodyweight with physiological saline as the vehicle.

There was no mortality and no clinical signs related to the test material were observed after 14 days following treatment. Bodyweight losses of 10 to 128 g were noted for four animals at day 7 and in one animal at day 14. Dermal irritation was severe and consisted of slight to severe erythema and edema, and slight to marked atonai, desquamation, coriaceousness, and fissuring. Other dermal effects included subcutaneous hemorrhaging, blanching, possible necrotic areas, eschar, exfoliation, and possible scar tissue.

In conclusion, the LD50 value for acute dermal toxicity was found to be greater than 2000 mg/kg bodyweight.