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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
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

Constituent 1
Chemical structure
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
Specific details on test material used for the study:
- Name of test material (as cited in study report): sodium formate
- Substance type: salt
- Physical state: solid
- Analytical purity: 100%
- Lot/batch No.: 1292066

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:
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.

Body weight:
Mean male body weights on day 0, day 7, and day 14: 269/285/311 g
Mean female body weights on day 0, day 7, and day 14: 222/225/236 g
Gross pathology:
No findings in organs of males and females.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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.