Registration Dossier
Registration Dossier
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EC number: 200-311-3 | CAS number: 57-09-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Jun-Jul 1984; Feb-Mar 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across to cetrimonium bromide from data on cetrimonium chloride (with data reliability value of 1). Read-across justifications are provided in the endpoint summary.
Data source
Reference
- Reference Type:
- other: SCCS opinion document
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Except study with 28-30% cetrimonium chloride, which was performed before EU GLP-guidelines
Test material
- Reference substance name:
- Cetrimonium chloride
- EC Number:
- 203-928-6
- EC Name:
- Cetrimonium chloride
- Cas Number:
- 112-02-7
- Molecular formula:
- C19H42N.Cl
- IUPAC Name:
- N,N,N-trimethylhexadecan-1-aminium chloride
- Test material form:
- other: 28-30% cetrimonium chloride in water; 24-26% cetrimonium chloride in wate
- Details on test material:
- The SCCS opinion document refers to two studies with cetrimonium chloride: 28-30% cetrimonium chloride in water and 24-26% cetrimonium chloride in water.
- Name of test material (as cited in study report): cetrimonium chloride
- Molecular formula (if other than submission substance): C19H42N.Cl
- Molecular weight (if other than submission substance): 320.0
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- water
- Remarks:
- 28-30% cetrimonium chloride in water; 24-26% cetrimonium chloride in wate
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- 0.1 ml of test substance
- Observation period (in vivo):
- Ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation of the test article. When ocular reactions were noted at 72 hours, additional examinations were performed at 7, 14 and 21 days after the instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A volume of 0.1 ml of the test substance was placed into the conjunctival sac of one eye of each animal. For 28-30% cetrimonium chloride treated eyes were rinsed thoroughly with physiological saline warmed to 37 °C after 24 hours. No informaiton on rinse of treated eyes was not given for the study with 24-26% cetrimonium chloride.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.9
- Remarks on result:
- other: 28-30% cetrimonium chloride
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Remarks on result:
- other: 28-30% cetrimonium chloride
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.3
- Remarks on result:
- other: 28-30% cetrimonium chloride
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 3.7
- Remarks on result:
- other: 28-30% cetrimonium chloride
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.8
- Remarks on result:
- other: 24-26% cetrimonium chloride
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.4
- Remarks on result:
- other: 24-26% cetrimonium chloride
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 4
- Remarks on result:
- other: 24-26% cetrimonium chloride
- Irritant / corrosive response data:
- For 28-30% cetrimonium chloride: Grade 1-2 corneal opacity was found at time points between 1 and 72 hours. At 7, 14 and 21 days, grade 3 corneal opacity was noted. Grade 1 iritis was found at all time points between 1 hour and 7 days. No iritis was reported at 14 days and grade 1 iritis in 1/3
animals at 21 days. Conjunctival irritation was evident as grade 1-3 redness and grade 3-4 swelling at time points 24, 48 and 72 hours and still persisted as grade 1-2 redness and grade 2 swelling at 21 days.
For 24-26% cetrimonium chloride: The behaviour and physical condition of the rabbits were normal throughout the study. Grade 1 corneal opacity was observed at 1 hour and grade 3-4 opacity was found at all later time points including day 21. The iris could not be evaluated due to the corneal opacity. Conjunctival irritation was evident as grade 2-3 redness and grade 3-4 swelling at all time points including day 21.
Any other information on results incl. tables
Observation time |
Observations |
|
28-30% cetrimonium chloride |
24-26% cetrimonium chloride |
|
1 hour |
Grade 1-2 corneal opacity Grade 1 iritis |
Grade 1 corneal opacity Grade 2-3 redness Grade 3-4 swelling |
24 hours |
Grade 1-2 corneal opacity Grade 1 iritis Grade 1-3 redness Grade 3-4 swelling |
Grade 3-4 corneal opacity Grade 2-3 redness Grade 3-4 swelling |
48 hours |
Grade 1-2 corneal opacity Grade 1 iritis Grade 1-3 redness Grade 3-4 swelling |
Grade 3-4 corneal opacity Grade 2-3 redness Grade 3-4 swelling |
72 hours |
Grade 1-2 corneal opacity Grade 1 iritis Grade 1-3 redness Grade 3-4 swelling |
Grade 3-4 corneal opacity Grade 2-3 redness Grade 3-4 swelling |
7 days |
Grade 3 corneal opacity Grade 1 iritis |
Grade 3-4 corneal opacity Grade 2-3 redness Grade 3-4 swelling |
14 days |
Grade 3 corneal opacity |
Grade 3-4 corneal opacity Grade 2-3 redness Grade 3-4 swelling |
21 days |
Grade 3 corneal opacity Grade 1 iritis 1/3 Grade 1-2 redness Grade 2 swelling |
Grade 3-4 corneal opacity Grade 2-3 redness Grade 3-4 swelling |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the observations in the two studies it is concluded that cetrimonium chloride in aquaous solutions in the cocentration range from 24-30% cause irreversible ocular damage, corneal opacity and conjunctival irritation which persisted throughout the test period until day 21.
Reading-across to cetrimonium bromide this imply classification with Eye Dam 1 - Executive summary:
The SCCS opinion document refers to two studies with cetrimonium chloride: 28-30% cetrimonium chloride in water and 24-26% cetrimonium chloride in water. The studies were carried out according to OECD TG 405 with New Zealand white albino rabbits. A volume of 0.1 ml of the test substance was placed into the conjunctival sac of one eye of each animal. The untreatred eye served as control. Ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation of the test article. When ocular reactions were noted at 72 hours, additional examinations were performed at 7, 14 and 21 days after the instillation.
For 28 -30% cetrimonium chloride, the mean score values of the 24, 48 and 72 hour readings were 1.9 for opacity, 1.0 for iritis, 2.3 for conjunctival redness and 3.7 for conjunctival chemosis. Corneal opacity persisted throughout the test period until day 21. Conjunctival irritation and swelling persisted as grade 1 -2 redness and grade 2 swelling at 21 days.
For 24 -26% cetrimonium chloride, the mean score values of the 24, 48 and 72 hour readings were 2.8 for opacity, 2.4 for conjunctival redness and 4.0 for conjunctival chemosis. Corneal opacity persisted throughout the test period until day 21. Conjunctival irritation was evident as redness and sweling at all time points including day 21.
Based on the observations in the two studies it is concluded that cetrimonium chloride causes irreversible ocular damage, corneal opacity and conjunctival irritation which persisted throughout the test period until day 21.
Reading-across to cetrimonium bromide this imply classification with Eye Dam 1
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