Registration Dossier
Registration Dossier
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EC number: 923-108-8 | CAS number: 1187576-42-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2002)
- Principles of method if other than guideline:
- This testing strategy comprised a stepwise approach including the evaluation of existing human and/or animal data showing effects on the eye or the skin, the performance of a SAR evaluation for eye and skin corrosion/irritation, measurement of pH value, the evaluation of data on systemic toxicity via the dermal route, the performance of a validated in vitro test for skin corrosion (Human 3D Epidermal Skin Model) and in vivo testing for skin irritation/corrosion in rabbits before in vivo testing for eye irritation/corrosion in rabbits.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate
- EC Number:
- 923-108-8
- Cas Number:
- 1187576-42-6
- IUPAC Name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Crl:KBL(NZW)BR
- Sex: male
- Source: Charles River, 88353 Kißleg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.0-3.5 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The lids were gently held together for about one second in order to prevent loss of the test compound. The eye was rinsed with saline approximately 24 hours following instillation.
- Observation period (in vivo):
- Animals were monitored after application until the changes had completely subsided, however for not more than 21 days after application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 0.1 ml of the pure liquid test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound.
Because of the fact that one hour after treatment a severe irritation was not observed, a further two rabbits were treated as described.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was rinsed approximately 24 hours following instillation.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- #1, #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: grade 1 redness at 24 h only
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: grade 1 redness at 24 and 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Other effects:
- The control eyes did not show any abnormal findings.
There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Executive summary:
A well-conducted Acute Eye Irritation/ Corrosion test (OECD 405) was performed with the test substance. Under the conditions of the test only slight irritating effects were observed (conjunctivae redness score 1 after 24 hours, fully reversed after 48 hours). There were no systemic intolerance reactions.
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