Registration Dossier
Registration Dossier
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EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
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 / OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Centre International de Toxicologie
Test material
- Reference substance name:
- 2-methylpropyl-(R)-2-hydroxypropanoate
- EC Number:
- 407-770-0
- EC Name:
- 2-methylpropyl-(R)-2-hydroxypropanoate
- Cas Number:
- 61597-96-4
- Molecular formula:
- C7 H14 O3
- IUPAC Name:
- 2-methylpropyl-(R)-2-hydroxypropanoate
- Details on test material:
- - Name of test material (as cited in study report): D-(+)-Isobutyllactat
- Physical state: liquid
- Analytical purity: 99.5%
- Isomers composition: D/(D+L) = 99.4%
- Lot/batch No.: PR 596
- Storage condition of test material: 4°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cunicole du Val de Seile, 80160 Prouzel, Frankreich
- Weight at study initiation: mean: 2.6 ± 0.2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- no washed out
- Observation period (in vivo):
- 1, 24, 48, 72 hours and daily until day 7
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: as described in 84/449/EG Annex V B5 and J.O.R.F. (Journal officiel de la Republique Francaise) from 24th of october 1984
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: within 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
Any other information on results incl. tables
Eye Irritation Scores:
Readings |
Animal |
cornea |
Iris |
conjunctiva |
||
opacity |
area |
redness |
swelling |
|||
1 h |
1 |
0 |
0 |
1 |
1 |
3 |
2 |
0 |
0 |
1 |
1 |
3 |
|
3 |
0 |
0 |
1 |
1 |
2 |
|
24 h |
1 |
1 |
4 |
1 |
2 |
1 |
2 |
1 |
4 |
1 |
2 |
1 |
|
3 |
1 |
4 |
1 |
3 |
2 |
|
48 h |
1 |
1 |
4 |
1 |
2 |
0 |
2 |
1 |
4 |
1 |
2 |
0 |
|
3 |
1 |
4 |
1 |
2 |
1 |
|
72 h |
1 |
1 |
4 |
1 |
2 |
0 |
2 |
1 |
4 |
1 |
2 |
0 |
|
3 |
1 |
4 |
1 |
2 |
1 |
|
6 d |
1 |
1 |
2 |
0 |
0 |
0 |
2 |
1 |
2 |
0 |
0 |
0 |
|
3 |
1 |
1 |
0 |
0 |
0 |
|
7 d |
1 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
|
mean 24 - 72 h |
1 |
1.0 |
|
1.0 |
2.0 |
0.3 |
2 |
1.0 |
|
1.0 |
2.0 |
0.3 |
|
3 |
1.0 |
|
1.0 |
2.3 |
1.3 |
|
mean |
|
1.0 |
|
1.0 |
2.1 |
0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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