Registration Dossier
Registration Dossier
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EC number: 205-633-8 | CAS number: 144-55-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- Molecular formula:
- CH2O3.Na
- IUPAC Name:
- sodium hydrogen carbonate
- Details on test material:
- - Name of test material (as cited in study report): "Natriumhydrogencarbonat"
- Physical state: white solid
- Analytical purity: approx. 99.8%
- Lot/batch No.: of July 24, 1991
- Stability under test conditions: stable for at least 1 year
- Storage condition of test material: at room temperature
- Date of receipt: August 14, 1991
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach/D
- Age at study initiation: 8 months
- Weight at study initiation: ca. 2580 g
- Housing: individual accomodation
- Diet (e.g. ad libitum): Sniff rabbit diet K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12 /12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05-0.07 ml (bump volume) - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed thoroughly with tepid water
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD Guideline 405
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hr
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- All rabbits had a slight to moderate conjunctival erythema (scores 1-2) 1 hour after the instillation, which was resolved at 48 hours observation. Two out of three animals also exhibited mild chemosis (score 1), which was resolved at 24 hours observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not classified for eye irritation or corrosion.
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