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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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: GLP-compliant guideline study, no restrictions, fully adequate for assessment. In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
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:
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
Duration of exposure:
Removal of test substance: After 24 hrs of exposure, the exposed area was wiped free of excess test material.
Doses:
Doses 2000 mg/kg bw as a 1000 mg/ml aqueous slurry
No. of animals per sex per dose:
6

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:
other: 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 severi
Gross pathology:
NECROPSY FINDINGS: Not reported
Other findings:
POTENTIAL TARGET ORGANS: Skin.
SEX-SPECIFIC DIFFERENCES: Not reported

Applicant's summary and conclusion

Executive summary:

LD50 >2000 mg/kg bw