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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
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): natriumformiat
- Substance type: salt
- Physical state: white powder
- Analytical purity: 97%
Specific details on test material used for the study:
Name of test material (as cited in study report): natriumformiat
- Substance type: salt
- Physical state: white powder
- Analytical purity: 97%

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 2.9 kg

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 20-40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
Single treatment
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to table contained in OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no skin reactions noted except from a slight (grade 1) edema seen in one of 3 animals at 24 hours after application of the test substance. This reaction was fully reversible within one day.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sodium formate was not a skin irritant.
Executive summary:

In an OECD guideline 404 study sodium formate was tested for its skin irritating properties under GLP conditions in three rabbits. Skin reactions were scored at 24, 48, and 72 hours after treatment according to the table contained in said guideline.

There were no skin reactions noted except from a slight (grade 1) edema seen in one of 3 animals at 24 hours after application of the test substance. This reaction was fully reversible within one day. Thus, sodium formate lacks skin irritating properties (Försvarets Forskningsanstalt, 1988).

 

The study is considered to be fully valid and acceptable for assessment.