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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
Not available
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature source (documentation insufficient for assessment)
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2007

Materials and methods

Principles of method if other than guideline:
Eye irritation potential of castor oil was evaluated in rabbits after single ocular administration
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
IUPAC Name:
Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
Details on test material:
- Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
None

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
Reactions were scored 18 to 24 h after instillation
Number of animals or in vitro replicates:
Five
Details on study design:
SCORING SYSTEM: The individual numerical scores for each eye were added together and then divided by the number of eyes. An ocular injury score of 5.0 represents severe injury, and corresponds to necrosis (covering approximately three-fourths of the corneal surface) that is visible only after staining or a more severe necrosis covering a smaller area.


Results and discussion

In vivo

Results
Irritation parameter:
other: ocular injury score
Basis:
mean
Time point:
other: 18-24 h
Score:
1
Max. score:
20
Reversibility:
not specified
Irritant / corrosive response data:
An injury grade of 1 (maximum score possible = 20) was reported for castor oil
Other effects:
No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under test conditions, castor oil was found to be slightly irritating to rabbit eyes.
Executive summary:

In an ocular irritation study, 0.5 mL of undiluted castor oil was instilled into the eyes of five rabbits. The reactions were scored 18 to 24 h later.

An injury grade of 1 (maximum score possible = 20) was reported for castor oil.

Under the test conditions, castor oil was found to be slightly irritating to rabbit eyes.