Registration Dossier
Registration Dossier
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EC number: 208-863-7 | CAS number: 544-17-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium formate
- EC Number:
- 205-488-0
- EC Name:
- Sodium formate
- Cas Number:
- 141-53-7
- Molecular formula:
- CHO2Na
- IUPAC Name:
- sodium formate
- Details on test material:
- - Name of test material (as cited in study report): sodium formate
- Substance type: salt
- Physical state: solid
- Analytical purity: 100%
- Lot/batch No.: 1292066
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Füllinsdorf, Switzerland
- Age at study initiation: males 8-10 weeks, females 12-14 weeks
- Weight at study initiation: means: males 269 g; females 222 g
- Housing: single housing in Macrolon, type III cages
- Diet: complete diet from Kliba, Basel, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 40 cm²
- % coverage: 10
- Type of wrap if used: gauze and adhesive fleece (Fixomull stretch)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mgsodium formate/kg bw; 2.02 mL/kg bw
- Concentration (if solution): 99%
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 20 µL/kg bw
- Concentration (if solution): 1% - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- Signs and symptoms: at least daily
-- Body weight: determined before application (day 0), and weekly thereafter
- Necropsy of survivors performed: yes - Statistics:
- Probit analysis or a binominal test, depending on the results
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There was no mortality in male (0/5) or female rats (0/5).
- Clinical signs:
- other: There were no systemic clinical signs in male or female rats at any time. Specifically, there were no local skin reactions in male or female rats at any time.
- Gross pathology:
- No findings in organs of males and females.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 was therefore >2000 mg/kg bw in male and female Wistar rats.
- Executive summary:
In an OECD TG 402 study Wistar rats (5/sex) were administered sodium formate on the fur-clipped dorsal skin at 2000 mg/kg bw under semi-occlusive conditions for 24 hours and observed for 14 days. The study was conducted under GLP conditions. No mortality or clinical signs of toxicity, skin reactions and no effects on body weights were seen, and no changes were seen in any organs during necropsy. The LD50was > 2000 mg/kg bw (BASF AG, 2007).
The study is considered to be fully valid and acceptable for assessment.
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