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Toxicological information

Eye irritation

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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:
1990
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

Constituent 1
Chemical structure
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
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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