Sodium formate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 30th - November 3rd 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

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
- Analytical purity: 100%

Specific details on test material used for the study:

SAFEWAY SE; >97% Sodium formate; >98% purity. White crystalline powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: EA Prinzhorn, Germany
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Individual
- Diet: Not reported
- Water: Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30th October 1995 To: 3rd November 1995

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

Not applicable; single exposure

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three rabbits

Details on study design:

0.1 g of the unchanged test material was instilled into one (left) eye of three male NZW rabbits. The untreated (right) eye of each animal acted as a control. Ocular reactions were scored at up to 72 hours using the Draize scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

probability of mild irritation

Other effects:

Slight ocular secretion was also noted in all animals at the 1-hour observation.

Any other information on results incl. tables

Summary of ocular findings

Finding		1h	24h	48h	72h	Mean (24-72h)
Cornea	Opacity	0,0,0	0,0,0	0,0,0	0,0,0	0.00
Iris		0,0,0	0,0,0	0,0,0	0,0,0	0.00
Conjunctivae	Erythema	2,2,3	1,0,1	1,0,0	0,0,0	0.33
	Chemosis	1,1,2	0,0,1	0,0,0	0,0,0	0.11

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results of this study indicate that sodium formate causes moderate transient eye irritation and is not classified for eye irritation according to the CLP criteria.

Executive summary:

The eye irritation potential of sodium formate was investigated in a GLP- and guideline (OECD 405)-compliant rabbit study. 0.1 g of the unchanged test material was instilled into one (left) eye of three male New Zealand White rabbits.  The untreated (right) eye of each animal acted as a control.  Ocular reactions were scored at up to 72 hours using the Draize scale.There were no corneal or iridic effects in any rabbit. There were no corneal or iridic effects in any rabbit. Initial conjunctival erythema (Grade 2 or 3) was seen in all animals but had resolved or decreased in severity to Grade 1 by 24 hours. Findings had resolved in all animals by 72 hours. Initial conjunctival chemosis (Grade 1 or 2) was seen in all animals but had resolved or decreased in severity to Grade 1 by 24 hours. Findings had resolved in all animals by 48 hours. Slight ocular secretion was also noted in all animals at the 1-hour observation. The results of this study indicate that sodium formate causes moderate transient eye irritation and is not classified for eye irritation according to the CLP criteria.