Registration Dossier
Registration Dossier
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EC number: 614-925-8 | CAS number: 69098-08-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in accordance with GLP; low purity of the test substance (71.2 %)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl 3-methoxy-3-(4-methoxyphenyl)propanoate
- EC Number:
- 614-925-8
- Cas Number:
- 69098-08-4
- Molecular formula:
- C12 H16 O4
- IUPAC Name:
- methyl 3-methoxy-3-(4-methoxyphenyl)propanoate
- Details on test material:
- - Name of test material (as cited in study report): 3-(4-Methoxyphenyl)-3-methoxypropionsaueremethylester, technical grade
- Substance No.: 93/98
- Batch No.: Ansatz 165
- Purity: 71.2 %.
- Date of manufacturing: 22 Apr 1993
- Physical state: solid, brown; after heating at about 30 °C: liquid brown
- Storage condition of test material: REFRIGERATOR, EXCLUSION OF LIGHT AND AIR (UNDER NITROGEN), EXCLUSION OF MOISTURE
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Sex: 1 male, 2 females
- Age at study initiation: young adult animals
- Weight at study initiation: 3.52 kg, 3.43 kg, 3.40 kg
- Housing: single in stainles stell wire mesh cages with grating; floor area: 3000 cm2
- Diet: 130 g Kliba-Labordiaet per animal per day
- Diet: Kliba-Labordiaet, about 130 mg per animal/day
- Water: about 250 ml tap water/day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
- Heated at about 30°C - Duration of treatment / exposure:
- one application; the test substance was not washed out.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- APPLICATION
- The test substance was heated at about 30 deg C to become liquid and was then applied as such to the conjunctival sac of the right eyelid
READINGS
- 1, 24, 48 and 72 hours
SCORING SYSTEM:
According to OECD guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24h (2/3 animals), 48h (1/3 animals)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritant / corrosive response data:
- Except for a slight redness of the conjunctiva that was seen in each treated eye after 1 hour and a single case of discharge, no effects were reported. After 24 hours, redness of the conjunctiva only remained in one case and no more discharge was seen. After 72 hours, no adverse occular effects were observed in all animals.
Any other information on results incl. tables
Results:
| Readings | Animal | cornea | Iris | conjunctiva | Symptons | |||
| opacity | area | redness | swelling | discharge | ||||
| 1 h | 1 | 0 | 0 | 0 | 1 | 0 | 2 | |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 24 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 48 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 72 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| mean 24 - 72 h | 1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | |
| 2 | 0.0 | 0.0 | 0.0 | 0.3 | 0.0 | 0.0 | ||
| 3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| mean | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | ||
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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