Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
At this time a In-vivo study was performed and therefore covers this endpoint.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Hoechst AG, conventional breeding- Age at study initiation: 3 - 5 month- Weight at study initiation: 3.5 - 3.8 kg- Housing: individual in stainless stell cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 +/-3°C- Humidity (%): 50 +/- 20 %- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12 hour interval

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL of the undiluted test item
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24 hours (due to severe eye irritation reactions study was terminated after this reading)
Number of animals or in vitro replicates:
3
Details on study design:
24 hours in advance to the study, the later tested eye of each rabbit was treated with fluoresceine Na-salt (0.01%) in order to check the cornea concerning defects. Only animals without diagnostic findings regarding the cornea were choosen for further testings.For the study 0.1 mL of the test item (concentration is 78 %; composition reported in confidential details on test material) was applied to the conjunctival sac of the left eye of each testing animal. The non treated eye served as control eye.Damages on the cornea, the iris and on the conjunctiva were numerical evaluated. All other changes were also recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
all animals
Basis:
mean
Remarks:
over all
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
other: study terminated due to the severity of findings
Irritation parameter:
iris score
Remarks:
all animals
Basis:
mean
Remarks:
overall
Time point:
other: 24 hours
Remarks on result:
other: not assessable due to severe opacity of cornea
Irritation parameter:
conjunctivae score
Remarks:
all animals
Basis:
mean
Remarks:
overall
Time point:
other: 24 hours
Score:
3
Max. score:
3
Reversibility:
other: study terminated due to severity of findings
Irritation parameter:
chemosis score
Remarks:
all animals
Basis:
mean
Remarks:
over all
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
other: study terminated due to severity of findings
Irritant / corrosive response data:
At the 24 hour reading severe eye irritation in form of opaque cornea, non assessable iris and severe chemosis including white discoloration of conjunctivae occurred. Based hereupon the study was terminated and the animals humanly killed.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results, the test material is considered to be severly irritating to rabbit eyes.
Executive summary:

In an OECD TG 405 study, 0.1 ml of the test material was applied to the eye of 3 New Zealand White rabbit. From 1 hour onwards, the conjunctiva showed red beefy discoloration and pronounced chemosis. The cornea exhibited opalescent areas or was opaque with no details of the iris visible. Because these lesions had progressed at the 24 hour reading, the study was terminated and the animals humanly killed for animal welfare reasons. Accordingly, the test item has to be considered as severely irritating to eyes.