Registration Dossier
Registration Dossier
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EC number: 213-911-5 | CAS number: 1066-33-7
Eye irritation
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:
- 2 003
- Bibliographic source:
- SIDS Dossier Sodium Bicarbonate, Final July 2003
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Labs, New Jersey, USA
Test material
- Reference substance name:
- Sodium hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- IUPAC Name:
- sodium hydrogen carbonate
- Details on test material:
- - Name of test material (as cited in study report): sodium bicarbonate
- Analytical purity: > 99.5%
Constituent 1
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
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