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Registration Dossier
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EC number: 308-766-0 | CAS number: 98283-67-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 - 14 Dec 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The non-GLP study was performed equivalent to an appropriate OECD guideline. Only 10% (a.i.) was used in the study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Journal Officiel de la Republique Francaise (1992)
- Deviations:
- yes
- Remarks:
- Only 10% (a.i.) tested, limited study design information
- GLP compliance:
- no
Test material
- Reference substance name:
- Undecyl glucoside
- EC Number:
- 308-766-0
- EC Name:
- Undecyl glucoside
- Cas Number:
- 98283-67-1
- Molecular formula:
- (C6H10O5)nC11H24O, n - number of D-glucopyranose units
- IUPAC Name:
- (2R,3S,4S,5R)-2-(hydroxymethyl)-6-(undecyloxy)oxane-3,4,5-triol
- Test material form:
- other: fluid gel, not further specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- other: distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 55% product diluted to 18.2%, (i.e. 10% a.i.) - Duration of treatment / exposure:
- Single application with washing after 30 sec (right eye)
Single application without washing (left eye) - Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, 72 h and 4 and 7 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the eyes was only performed on the right eye 30 sec after application of the test material. The left eye remained unwashed.
- Time after start of exposure: 30 sec
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Corneal opacity was noted in 2/3 animals (grade 11) 1 h after application of the test material.24 h after application of the test material corneal opacity was observed in 3/3 animals (grade 2). These effects were fully reversible within 4 days (1/3 animals) and 7 days (2/3 animals), respectively. Iris effects (grade 1) were recorded in 1/3 animals 24 h after application of the test material, but being fully reversible within 48 h. Conjunctivae effects (grade 1) were observed in 3/3 animals 1 h, 24, 48 and 72 h after application of the test material. These effects were fully reversible within 4 days (2/3 animals) and 7 days (1/3 animals), respectively. Chemosis was observed in 1/3 (grade 1) and 2/3 (grade 2) animals 1 h after application of the test material, but these effects were fully reversible within 72 h (2/3 animals with initially grade 2) and 4 days (1/3 animals with initially grade 1).
- Other effects:
- No mortalities occured during the study period.
Any other information on results incl. tables
Table 1: Individual scores for corneal opacity, iris, conjunctivae and chemosis effects
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
chemosis |
||||
1
|
1 |
1 |
1 |
0 |
0 |
24 |
1 |
1 |
0 |
2 |
|
48 |
1 |
1 |
0 |
2 |
|
72 |
1 |
1 |
0 |
2 |
|
average |
1 |
1 |
0 |
2 |
|
2
|
1 |
1 |
2 |
0 |
1 |
24 |
1 |
1 |
0 |
2 |
|
48 |
1 |
1 |
0 |
2 |
|
72 |
1 |
0 |
0 |
2 |
|
average |
1 |
0.67 |
0 |
2 |
|
3
|
1 |
1 |
2 |
0 |
1 |
24 |
1 |
1 |
1 |
2 |
|
48 |
1 |
1 |
0 |
2 |
|
72 |
1 |
0 |
0 |
2 |
|
average |
1 |
0.67 |
0.33 |
2 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the experimental conditions performed equivalent or similar to OECD TG 405 the test material appeared to be irritating to eyes when applied as 10% (a.i.) formulation.
SCL (worst case assumption due to lack of data for neat substance):
Eye Irrit. Cat. 2 ≥1% (a.i.) and ≤10% (a.i.)
Eye Dam. Cat. 1 >10% (a.i.)
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