Registration Dossier
Registration Dossier
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EC number: 203-602-3 | CAS number: 108-64-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-09-06 to 1999-09-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methylbutyl isovalerate
- EC Number:
- 211-536-1
- EC Name:
- 3-methylbutyl isovalerate
- Cas Number:
- 659-70-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 3-methylbutyl 3-methylbutanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißlegg
- Weight at study initiation: 1.8 to 1.9 kg
- Housing: individually in PPO cages
- Diet (e.g. ad libitum): pelleted complete rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3°c
- Humidity (%): 55%+-15%
- Air changes (per hr): 10 air changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml per application
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h and 7 d
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with 20 ml 0.9% sodium chloride solution
- Time after start of exposure: 24 h after exposure
SCORING SYSTEM:
- According to OECD guideline.
TOOL USED TO ASSESS SCORE: fluorescein / UV-lamp
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:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 0.33
- Reversibility:
- fully reversible
Any other information on results incl. tables
Scores for ocular lesions
| Rabbit No. | Individual mean score from readings after 24, 48 and 72 hours | |
| 1623 | Cornea opacity, degree | 0.00 |
| Iris | 0.00 | |
| Conjunctiva Redness | 0.67 | |
| Chemosis | 0.00 | |
| 1624 | Cornea opacity, degree | 0.00 |
| Iris | 0.00 | |
| Conjunctiva Redness | 1.00 | |
| Chemosis | 0.33 | |
| 1625 | Cornea opacity, degree | 0.00 |
| Iris | 0.00 | |
| Conjunctiva Redness | 0.67 | |
| Chemosis | 0.00 | |
| 1626 | Cornea opacity, degree | 0.00 |
| Iris | 0.00 | |
| Conjunctiva | 0.00 | |
| Chemosis | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is non irritating to the eye according to GHS criteria.
- Executive summary:
The test item was tested for eye irritation in an in-vivo test in rabbits (according to OECD 405 and GLP). Four rabbits had the test item instilled in the left eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as day 7 after dosing. Slight signs of irritation were observed on the treated eyes. By 7 days, 4 of 4 treated eyes had returned to normal. It is concluded that the substance is not irritating to the eyes of rabbits under the conditions of the study.
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