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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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): 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

Resultsopen allclose all
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
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
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
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.