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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data taken from OECD SIDS; guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
SIDS Initial Assessment Report For SIAM 15
Author:
OECD
Year:
2003
Bibliographic source:
SIDS Dossier Sodium Bicarbonate, Final July 2003
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Remarks:
Product Safety Labs, New Jersey, USA

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sodium bicarbonate
- Analytical purity: > 99.5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit remained untreated and served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
one instillation
Observation period (in vivo):
1, 24, 48 and 72 h and at 4 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 6 animals: no rinsing; 3 animals: rinsing with 30 ml of physiological saline
- Time after start of exposure: ca. 20 - 30 sec


SCORING SYSTEM:
- Ocular lesions were evaluated by the method of Draize et al. The scores were further classifled by the System of Kay and Calandra, modified.

OTHER EXAMINATION
- Ophtalmoscopic examination: the incidence of irritation was evaluated by corneal opacity, iritis and conjunctival irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 3-4 days
Remarks on result:
other: rinsed eyes
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
8.3
Max. score:
110
Reversibility:
fully reversible within: 3-4 days
Remarks on result:
other: not rinsed eyes

Any other information on results incl. tables

NUMBER OF INCIDINCES
- Cornea: 0/6 (not rinsed eye) and 0/3 (rinsed eye) at all evaluations.
- Iris: Not rinsed eyes: 1 hr, 1/6; 24 hrs, 0/6; 48 hrs, 0/6; 72 hrs 0/6; 4 days, 0/6. Rinsed eyes: 1 hr, 1/3; 24 hrs, 0/3; 48 hrs, 0/3; 72 hrs 0/3; 4 days, 0/3.
- Conjuntivae (Redness): According to the applied assessment system, conjunctivae consists of hyperaemia, chemosis and discharge.

Not rinsed eyes: 1 hr, 6/6; 24 hrs, 6/6 ; 48 hrs, 6/6; 72 hrs 1/6; 4 days, 0/6. Rinsed eyes: 1 hr, 3/3; 24 hrs, 2/3; 48 hrs, 1/3; 72 hrs 0/3; 4 days, 0/3.

OVERAL IRRITTATION SCORE

The 24 hour Maximum Mean Total Score (MMTS) for the rinsed eyes was 2.0 (practically non-irritating). The 24 hour Maximum Mean Total Score (MMTS) for the not rinsed eyes was 8.3 (minimally irritating). The authors classified the substance as practically non-irritating to the rinsed eye and minimally irritating to the not rinsed eye.

DESCRIPTION OF LESIONS

No corneal opacity was noted during the study. One rinsed and one not rinsed eye exhibited iritis one hour after installation only. All treated eyes had conjunctivitis. The incidence and severity of irritation decreased with time. All ocular irritation cleared from the rinsed and not rinsed eyes by days 3 and 4, respectively.

REVERSIBILITY

The effects were fully reversible.

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating