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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
EC Number:
926-072-1
Cas Number:
198479-63-9
Molecular formula:
C29H25NO2
IUPAC Name:
3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
escription: solid
Batch Number: 0010211968
Purity: 98.1%
stability of test item: Stable under storage conditions
Expiry date: 03-Mar-2002
Storage conditions: In the original container, at room temperature (range of 17-23°C), away from direct sunlight.
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single dose
Observation period (in vivo):
Scoring of irritation effects was performed app. 1, 24, 48 and 72 hours after application.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 & 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
0.33
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Application of the test item to healthy rabbit conjunctivae resulted in a primary eye irritation score of 0.11. The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.11 redness of the conjunctivae and grade 0.00 chemosis of the conjunctivae. No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight to moderate reddening of the cornea was observed in all animals 1 hour after treatment and slight reddening continued to be observed in one animal up to the 24 hour reading. Slight swelling of the conjunctivae was evident in all animals 1 hour after treatment. Slight to moderate reddening of the sclerea was apparent in all animals at the 1 hour reading. No abnormal findings were observed in the treated eye, of any animal, 48 hours after treatment.

No staining of the treated eyes by the test item was observed. Beige coloured remnants of the test item were observed in the eye or conjunctival sac of one animal at the 1 -hour reading.

No corrosion of the cornea was observed at any of the reading times.

The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), TSE 2 is considered to be "not irritating" to the rabbit eye.

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