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Registration Dossier
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EC number: 205-290-4 | CAS number: 137-40-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 May 2016 -08 August 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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 propionate
- EC Number:
- 205-290-4
- EC Name:
- Sodium propionate
- Cas Number:
- 137-40-6
- Molecular formula:
- C3H6O2.Na
- IUPAC Name:
- sodium propionate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: EUROLAP (F-3510 GOSNE)
- gender: male
- Age at study initiation: 10-14 weeks
- Housing: each animal was kept in an individual box
- Diet: foodstuff (ENVIGO, 2030C), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees Celsius
- Humidity (%): 30-70%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): light/dark: 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
SCORING SYSTEM: Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 hours following treatment. Scoring was carried out following the score system as per OECD 405.
TOOL USED TO ASSESS SCORE: expert evaluation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight and totally reversible:
caculated means:
cornea opacity: animal#1 0.0, animal #2 0.7, animal#3 0.3
iris lesion: animal#1 0.0, animal #2 0.7, animal#3 0.3
conjunctivae chemosis: animal#1 0.3, animal #2 1.0, animal#3 1.0
conjunctivae redness: animal#1 1.3, animal #2 1.0, animal#3 1.3
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained enable to conclude that sodium propionate does not have to classified as corrosive/irritant to the eye.
No symbol and warning label are required. - Executive summary:
An acute eye irritation study of the test item was performed according to OECD 405 under GLP conditions.
The test item was instilled, as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1g, after treatment with analgesic and anaesthetic. Initially, a single animal was treated and, after consideration of the responses in the first animal, two additional animals were treated in the same experimental conditions. The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The eyes were examined at 1, 24, 48 and 72 hours after application.
The test item, when applied to rabbit eye mucosa, caused slight to important reactions, all totally reversible. At the conjunctivae level, moderate redness was noted 1h after instillation associated with slight to important chemosis, totally reversible between days 2-7. At the iris level, injection was noted in 2/3 animals 1h after instillation, and totally reversible between days 2-3. At the corneal level, slight opacity was noted in 2/3 animals 24h after instillation, totally reversible between days 2-3.
The results obtained enable to conclude that sodium propionate does not have to be classified as corrosive/irritant to the eye. No symbol or warning label are required.
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