Registration Dossier
Registration Dossier
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EC number: 287-619-1 | CAS number: 85563-48-0
Eye irritation
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:
- other: scientifically acceptable study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- based on the Proposed Guidelines of the United States Environmental Protection Agency (EPA), § 163.81-5 "Primary eye irritation study", Fed. Reg. 43, No. 163, 1978
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate
- EC Number:
- 287-619-1
- EC Name:
- Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate
- Cas Number:
- 85563-48-0
- Molecular formula:
- C20H44NO.H2O4P
- IUPAC Name:
- dihydrogen hexadecyl(2-hydroxyethyl)dimethylazanium phosphate
- Test material form:
- other: liquid
- Details on test material:
- Name of the test substance used in the study report: FAT 75'174/A
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Initial body weight range: 2 - 3 kg
- Animal identification: ear numbers
- The animals were housed individually in metal cages.
- The animal room was air-conditioned: room temperature 22 +/- 3°C, relative humidity 55 +/- 15%, 12 h light and 12 h darkness, approx. 15 air changes per hour.
- Adaptation period: 4 days
- The animals were offered a standardized animal laboratory diet and water ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (3 males, 3 females)
- Details on study design:
- - The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.
- The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment and was scored for each iridividual rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: unrinsed and rinsed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: unrinsed and rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed eye
Any other information on results incl. tables
|
Redness |
Chemosis |
Opacity |
Iris |
|||||||||||||
Animal |
24 h |
48 h |
72 h |
Mean |
24 h |
48 h |
72 h |
Mean |
24 h |
48 h |
72 h |
Mean |
24h |
48 h |
72 h |
Mean
|
|
1 |
Unrinsed (male) |
3 |
3 |
3 |
3.0 |
3 |
3 |
3 |
3.0 |
1 |
1 |
1 |
1.0 |
1 |
1 |
1 |
1.0 |
2 |
3 |
3 |
3 |
3.0 |
3 |
3 |
3 |
3.0 |
2 |
2 |
2 |
2.0 |
1 |
1 |
1 |
1.0 |
|
3 |
3 |
3 |
3 |
3.0 |
3 |
3 |
2 |
2.7 |
1 |
1 |
1 |
1.0 |
1 |
1 |
1 |
1.0 |
|
4 |
Rinsed (female) |
3 |
3 |
3 |
3.0 |
3 |
2 |
2 |
2.3 |
1 |
1 |
1 |
1.0 |
1 |
1 |
1 |
1.0 |
5 |
3 |
3 |
3 |
3.0 |
2 |
2 |
2 |
2.0 |
1 |
1 |
1 |
1.0 |
1 |
1 |
1 |
1.0 |
|
6 |
3 |
3 |
3 |
3.0 |
3 |
2 |
2 |
2.3 |
1 |
1 |
1 |
1.0 |
1 |
1 |
1 |
1.0 |
|
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:
- Under the conditions of the present study the test item was found to possibly cause irreversible effects on the eye.
- Executive summary:
The test material was inserted in an amount of 0.1ml in the conjunctival sac of the left eye of six New Zealand White Rabbits. The right eye was not treated and served as negative control. In 3 of 6 animals approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48 and 72 hours and 4 and 7 days after treatment and was scored for each individual rabbit. Under the conditions of the present study the test item was found to possibly cause irreversible effects on the eye.
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