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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA 16 CFR 1500.40
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium carbonate
EC Number:
207-838-8
EC Name:
Sodium carbonate
Cas Number:
497-19-8
Molecular formula:
CH2O3.2Na
IUPAC Name:
disodium carbonate
Details on test material:
SOURCE: Not reported.
PURITY: Not reported.
IMPURITY/ADDITIVE/ETC.: Not reported.
ANY OTHER INFORMATION: The test substance was sodium
carbonate monohydrate.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: New Zealand White Albino Rabbits.
- Source: Marland Breeding Farms, Inc., Hewitt, NJ.
- Age: Not reported.
- Weight at study initiation: 2.50-3.40 kg.
- Controls: Not reported. 3 animals had abraded skin, and 3 animals had non-abraded skin.

Administration / exposure

Vehicle:
water
Details on dermal exposure:
ADMINISTRATION: The hair of each rabbit was clipped from the trunk so as to expose at least 30% of the body surface area. The skin of half the animals was abraded longitudinally every two or 3 cm over the area of exposure. The operations were deep enough so as to penetrate the stratum corneum, but not so deep as to disturb the derma or produced bleeding.
- Area covered: The test material was administered to the clipped area.
- Occlusion: The test material was held in contact with the skin by a sleeve made of impervious plastic sheeting designed to contain the dose without leakage or undue pressure.
- Concentration in vehicle: the test material was administered as a 1000 mg/ml aqueous slurry.
- Total volume applied: Not reported.
- Doses: 2000 mg/kg.
- Removal of test substance: After 24 hrs of exposure, the exposed area was wiped free of excess test material.
Doses:
2000 mg/kg bw as a 1000 mg/ml aqueous slurry.
No. of animals per sex per dose:
6
Statistics:
STATISTICAL METHODS: Not reported.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred during the experiment.
Clinical signs:
3/6 animals gained weight during the 14 days the experiment lasted. 3/6 animals lost weight or did not gain weight. Well-defined to severe erythema and slight to severe oedema were observed in all six animals at the 24-hour dermal observations. The severity of the lesions did not vary significantly between the animals with abraded or non-abraded skin. Lethargy and hypernea were observed in each animal during the first 24 hrs following compound administration.
Gross pathology:
NECROPSY FINDINGS: Not reported.
Other findings:
POTENTIAL TARGET ORGANS: Skin.
SEX-SPECIFIC DIFFERENCES: Not reported.

Applicant's summary and conclusion