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SODIUM CARBONATE CAS N°: 497-19-8 - UNEP Chemicals

SODIUM CARBONATE CAS N°: 497-19-8 - UNEP Chemicals

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OECD SIDS <strong>SODIUM</strong> <strong>CARBONATE</strong><br />

5. TOXICITY Id <strong>497</strong>-<strong>19</strong>-8<br />

Date <strong>19</strong>.02.2003<br />

64<br />

- Controls: Not reported.<br />

ADMINISTRATION/EXPOSURE<br />

- Preparation of test substance: The test material was administered as an<br />

aqueous slurry.<br />

- Area of exposure: The rabbits were closely clipped over the back and<br />

sides. There were to test sites for rabbit, each site 1 inch by 1 inch in area.<br />

The site to the left of the spinal column was abraded, while the sites to the<br />

right of the spinal column was left intact. The abrasions were sufficiently<br />

deep so as to penetrate the stratum corneum, but not so deep as to disturb<br />

the derma or produce bleeding.<br />

- Occlusion: A surgical gauze square a 1 inch by 1 inch, 8 single layers<br />

thick, was based on directly on the test site and secured with Dermicel tape.<br />

The animals were then wrapped with plastic sheeting secured with masking<br />

tape.<br />

- Vehicle: Water.<br />

- Concentration in vehicle: 1 gram/ml.<br />

- Total volume applied: 0.5 ml<br />

- Postexposure period: The animals were observed for 72 hrs after<br />

application.<br />

- Removal of test substance: After 24 hrs the sheeting and gauze patches<br />

were removed. It is not reported whether the test substance was cleaned<br />

from the application area.<br />

EXAMINATIONS<br />

- Scoring system: The Draize method.<br />

- Examination time points: Observations for signs o f dermal irritation or<br />

systemic toxicity were recorded at 24 and 72 hrs after application. All<br />

treated sides were scored for erythema, eschar, and oedema formation.<br />

Test substance : SOURCE: Not reported.<br />

PURITY: Not reported.<br />

IMPURITY/ADDITIVE/ETC.: Not reported.<br />

ANY OTHER INFORMATION: The test substance was sodium carbonate<br />

monohydrate.<br />

Reliability : (1) valid without restriction<br />

Guideline study<br />

14.02.2003 (23)<br />

Species : human<br />

Concentration : .2 g<br />

Exposure : no data<br />

Exposure time : 4 hour(s)<br />

Number of animals : 26<br />

Vehicle : water<br />

PDII :<br />

Result : not irritating<br />

Classification :<br />

Method : other: human patch test<br />

Year : <strong>19</strong>96<br />

GLP : yes<br />

Test substance : other TS: sodium carbonate<br />

Method : METHOD FOLLOWED: Human patch test procedure slightly modified from<br />

that described earlier (Basketter et al. <strong>19</strong>94). Developed for humans to<br />

replace method described by OECD guideline 404. Volunteers were<br />

exposed for 15, 30 or 60 minutes, or up to 2, 3 or 4 hours using patches<br />

with Hill Top Chambers. Solids were moistened. Scores were assessed 24,<br />

48 and 72 hours after patch removal using a 4 -point scale.<br />

GLP: Yes.<br />

STATISTICAL METHODS: Fisher's exact test was used to compare overall<br />

rectivity.<br />

METHOD OF CALCULATION: Not reported.<br />

ANALYTICAL METHODS: Not reported.<br />

<strong>UNEP</strong> Publications

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