Registration Dossier
Registration Dossier
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EC number: 294-589-3 | CAS number: 91744-27-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Apr 1990 to 07 May 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- other: J. Europ. Commun. L 251, 27, 109-112
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, castor-oil mono-, di- and tri-
- EC Number:
- 294-589-3
- EC Name:
- Glycerides, castor-oil mono-, di- and tri-
- Cas Number:
- 91744-27-3
- Molecular formula:
- C21H40O5 – C57H104O9
- IUPAC Name:
- Glycerides, castor-oil mono-, di- and tri-
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name as cited in study report: Loxiol G 11 / Glyceride, Ricinusöl Mono-. Di- und Tri
- Charge: 0419-0-040
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach/ Germany
- Age at study initiation: 8 to 9 months
- Weight at study initiation: ca. 2580 g
- Housing: Individually in Rabbit batteries of Fa. Heinkel, 7343 Kuchen/ Germany
- Diet: Altromin-Haltungsdiät 2023 Fa. Altromin GmbH, Lage/ Germany, ad libitum
- Water: Tapwater, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 45 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL undiluted substance
- Duration of treatment / exposure:
- 24 hours, after application the eyelids were shortly closed.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
24 hours after exposure, the eye was thoroughly washed with warm water to end the exposure.
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours and 7 and 14 days after exposure the effects were scored. After 24 hours and 14 days the eye was stained with fluorescein and a split lamp was used for assessment.
SCORING SYSTEM:
The scoring criteria were according to guidance 84/449/EWG (EC document L251/112):
- Corneal opacity
0 = No ulceration or opacity
1 = Scattered or diffuse opacity areas, details of the iris clearly visible
2 = Easily recognizable translucent areas, details of the iris somewhat shaded
3 = Pearly areas, no details of the iris visible, size of the pupil hardly recognizable.
4 = Opaque cornea, iris not recognizable due to opacity was used for assessment.
- Iris score
0 = Normal
1 = Pronounced deepened folds, congestion, swelling, slight circumcorneal hyperemia or injection: one of these symptoms or a combination. The iris reacts to light (slow reaction is positive).
2 = No reaction to light, hemorrhage or severe destruction (one or all symptoms).
- Conjunctiva redness and/ or nictitating membrane
0 = Blood vessels normal
1 = Some blood vessels show a marked hyperemia (Injection)
2 = Diffuse, crimson color, individual vessels difficult recognizable
3 = Completely red
- Chemosis
0 = No swelling
1 = Any swelling over the normal (including nictitating membrane)
2 = Clear swelling with partial return of the eyelids
3 = Swelling with slightly half-closed lids
4 = Swelling with more than half-closed lids
- Additional test evaluation: exudation
0 = no exudation
1 = low exudation
2 = clear exudation, moistening of the hair in the eye area
3 = strong exudation, moisturizing significantly over the eye area
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- 1 hour after application exudation was observed (grade 3 in animal #1 and #2 and grade 1 in animal #3)
1 hour after application chemosis was observed in animal #1.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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