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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:
1980-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Method: other: Draize Test according to Consumer Product Safety Commission (U.S.), Code of Federal Regulations, Title 16, Section 1500.42; 
Evaluation with Draize scores
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
3-aminomethyl-3,5,5-trimethylcyclohexan-1-ol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: New Zealand white
- Source: J. Scheele, Büderich/Westf., 4760 Werl

Housing conditions:
- Room temperature: 20°C (+/- 1°C);
- Light: 12 hours/day;
- Access to drinking water: ad libitum;
- Diet: K4 diet for rabbits (Ssniff; Soest)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
not rinsed
no removal of test substance
Observation period (in vivo):
Ophthalmoscopic examination after 24, 48, 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
Scoring system: Draize (1959)

Results and discussion

In vivo

Results
Irritation parameter:
other: Very strong reactions after 24h observation so that all animals were killed
Remarks:
Based on very strong reactions a score could not determined.
Time point:
24 h
Score:
20
Max. score:
20
Reversibility:
not reversible
Remarks on result:
probability of severe irritation

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
Under conditions of the study test item showed necrosis effects to rabbit eyes. Due to the severe damage of the eyes, rabbits were euthanized 24 after application.
Executive summary:

The acute eye irritation properties of the test item were estimated in a Draize test. An amount of 0.1 ml of the undiluted test substance was instilled into one eye of each of six albino rabbits, and the untreated eye served as control. The eyes are not washed following instillation of test material.

24 hours after application all animals showed necrosis effects on the eyes. Due to the severe damage of the eyes, rabbits were euthanized 24 after application.