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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Safety Assessment of Formic Acid and Sodium Formate as Used in Cosmetics.
Author:
Johnson Jr, W., Heldreth, B., Bergfeld, W.F., Belsito, D.V., Hill, R.A., Klaassen, C.D., Liebler, D.C., Marks Jr, J.G., Shank, R.C., Slaga, T.J. and Snyder, P.W.
Year:
2016
Bibliographic source:
International Journal of Toxicology, 35(2_suppl), pp.41S-54S; 2016

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The primary ocular irritation of Sodium formate was assessed in rabbits
GLP compliance:
not specified

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:
CH2O2.Na
IUPAC Name:
Sodium formate
Test material form:
solid
Details on test material:
Name of the test chemical: Sodium formate
Molecular Formula:CH2O2.Na
Molecular Weigth: 69.02 g/mol
InChI: 1S/CH2O2.Na/c2-1-3;/h1H,(H,2,3);/q;+1/p-1
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: Sodium formate
Molecular Formula:CH2O2.Na
Molecular Weigth: 69.02 g/mol
InChI: 1S/CH2O2.Na/c2-1-3;/h1H,(H,2,3);/q;+1/p-1
Substance Type: Organic
Physical State: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: at least 8 weeks old
- Sex: Male and female

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml, powder
Duration of treatment / exposure:
no data available
Observation period (in vivo):
Reactions were scored at 1,24,48 and 72 hours, and 7,10,14 and 17 days post-instillation
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6 rabbits (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: lower conjunctival sac of left eye

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 17 days
Score:
0
Reversibility:
fully reversible within: 17 days
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Moderate to severe conjunctival irritation was observed in all rabbits and conjunctival necrosis was observed in 4 of 6 rabbits. All reactions had cleared by 17 days.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Moderate to severe conjunctival irritation was observed in all rabbits and conjunctival necrosis was observed in 4 of 6 rabbits. All reactions had cleared by 17 days.
Since the effects are fully reversible in 17 days, hence Sodium formate can be considered to be not irritating to eyes.
Executive summary:

The ocular irritation potential of Sodium formate was assessed in 6 New Zealand White rabbits (3 males, 3 females).

Sodium formate (0.1 ml, powder) was instilled in the lower conjunctival sac of the left eye of the rabbits. The right eye remained untreated and served as control.Reactions were scored at 1, 24, 48 and 72 hours, and 7,10,14 and 17 days post-instillation.

Moderate to severe conjunctival irritation was observed in all rabbits and conjunctival necrosis was observed in 4 of 6 rabbits. All reactions had cleared by 17 days.

Since the effects are fully reversible in 17 days, hence Sodium formate can be considered to be not irritating to eyes.