Registration Dossier
Registration Dossier
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EC number: 255-578-9 | CAS number: 41892-01-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
- EC Number:
- 255-578-9
- EC Name:
- (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
- Cas Number:
- 41892-01-7
- Molecular formula:
- C17H37ClNO.Cl
- IUPAC Name:
- (3-chloro-2-hydroxypropyl)dodecyldimethylammonium chloride
Constituent 1
- Specific details on test material used for the study:
- Concentration: 27.87%, Denisty 1.07 g/ml, pH 7.1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or tissues and environmental conditions:
- Animals were 6 months old, 2.0 - 2.3 kg.
Environmental conditoons: Room temperature: 22°C +/- 2°C, relative humidity: 55% +/- 15%
Laboratory and cage cleaning by means of standard antiseptics, instrument and instrument disinfection by autoclave and hot-air sterilizer. Water ad libitum, drinking water quality.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- Examination period; 1, 24, 48, 72 hours post-application; then once daily. Observation period 21 days
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- 0.1 ml of the test substance was transferred once into the conjunctival sac of the right eye. Subsequently, both lids were kept closed for a short time by slight finger pressure. The left eye of each animal remained untreated and served as a control. On the basis of the results of the initial test, two further series of trials were applied to the mucosa with a duration of 4 and 30 seconds. After the exposure time, the eye was rinsed with lukewarm, flow rate approx. 150 ml / min.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 85
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- In addition to the irritant effects, there was pemanent tissue damage to the conjuctiva.
- Other effects:
- A test with a limited exposure time (4 and 30 seconds) and subsequent wash out of the substance in 6 animals caused removal of the conjunctival mucous membrane from the matrix. In these places acute bleeding occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Due to some permanant tissue damage to the conjunctiva in all 3 tests, the substance should be classified as Catgory 1, Irreversible Eye Effects.
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