Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Number of animals and purity not given.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1965

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
0.5 ml undiluted TS into the conjunctival sac of the eye.control substance: sodium saline, reading : 1 hour, 24 hours and 8 days after application of TS
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
DCHA undiluted

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
other: none
Controls:
not specified
Amount / concentration applied:
0,5 ml of DCHA
Duration of treatment / exposure:
Unspecified
Observation period (in vivo):
1h, 24h, 8d
Number of animals or in vitro replicates:
No data
Details on study design:
not available

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other:
Time point:
other: 1h
Reversibility:
not specified
Remarks on result:
other: slight redness, strong edema, slight cloudiness
Irritation parameter:
other:
Time point:
other: 24h
Reversibility:
not specified
Remarks on result:
other: marked redness, marked edema, slight cloudiness
Irritation parameter:
other:
Time point:
other: 8d
Reversibility:
not specified
Remarks on result:
other: marked redness
Irritant / corrosive response data:
finding 1 hr post appl.: slight redness, strong edema, slight cloudiness
---finding 24 hrs post appl.: marked redness, marked edema, slight cloudiness
---finding 8 days post appl.: marked redness

NaCl-control substance caused no adverse reactions in the eye.

Any other information on results incl. tables

NaCl (control substance) caused no adverse reactions in the eye.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
DCHA was found to be highly irritating to the eye of the rabbit.
Executive summary:

0.5 ml of undiluted DCHA was applied to the conjunctival sac of the rabbit eye, reading : 1 hour, 24 hours and 8 days after application, with the result - highly irritating.