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Diss Factsheets

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:
comparable to guideline study

Data source

Reference
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride
EC Number:
221-083-1
EC Name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride
Cas Number:
3001-63-6
Molecular formula:
C23H49ClNO.Cl
IUPAC Name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylazanium chloride
Constituent 2
Chemical structure
Reference substance name:
Propane-1,2-diol
EC Number:
200-338-0
EC Name:
Propane-1,2-diol
Cas Number:
57-55-6
Molecular formula:
C3H8O2
IUPAC Name:
propylene glycol
Test material form:
liquid
Details on test material:
Aqueous solution
Specific details on test material used for the study:
pH 5.85, Density: 0.99 g/ml

Test animals / tissue source

Species:
rabbit
Strain:
other: White russian (albino)
Details on test animals or tissues and environmental conditions:
Gender: Male, Mass: 2.0 - 2.3 kg, Age: Approximately 5 - 6 months, Acclimatization time before start of test: 1 day
Habitat: Stainless steel cages Model I Asta, Animals per cage: 1, Feeding: Standardized test animal feed, Hydration: Water ad libitum, Room temperature: 22°C +/- 1°C
Relative humidity: 50 - 60%, Lighting:12 hrs artificial light / 12 hrs darkness, Room hygiene: Laboratory and cage cleaning using standard antiseptics, instrument disinfection and sterilization by autoclave and hot air sterilizer.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml / animal
Observation period (in vivo):
1, 24, 48 and 72 hours after the administration of the test substance and then
Number of animals or in vitro replicates:
3
Details on study design:
0.1ml of the test product was placed in the conjunctival sac of an eye after the respective lower eyelid had been carefully pulled back from the eyeball. Subsequently the lids were replaced by light finger pressure for about 1 second to prevent the loss of test substance. The other eye of each animal remained untreated and served as a control. After the administration of the test substance the treated eyes were not treated with eye-wash. The eyes were examined periodically with an opthalmascope.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
not determinable
Remarks:
The observed clinical symptoms did not permit assessment according to prescribed methodology and the determination of the degree of irritancy had therefore to be dispensed with
Irritant / corrosive response data:
Within the first hour after the contact of the test product with the conjunctival mucosa, they were separated and dissolved. A spreading excessive inflammatory reaction was accompanied by severe painful expressions of the animals during the forcible opening of the eyelids. The treated eyes reacted with persistent ptosis. The observed clinical symptoms did not permit assessment according to prescribed methodology and the determination of the degree of irritancy had therefore to be dispensed with.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test substance is corrosive to eyes.