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EC number: 811-605-1 | CAS number: 37318-95-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- National guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics" by the Staff of the Division of Pharmacology", FDA, according to Draize (1959)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,3-dihydroxypropyl laurate
- EC Number:
- 205-526-6
- EC Name:
- 2,3-dihydroxypropyl laurate
- Cas Number:
- 142-18-7
- Molecular formula:
- C15H30O4
- IUPAC Name:
- 2,3-dihydroxypropyl laurate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.4-2.6 kg
- Housing: individually caged
- Diet: standard diet (Höing 222), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 2, 8, 24, 48 and 72 h and 4, 5, 6 and 7 days - Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritant / corrosive response data:
- Within the first 1, 2 and 8 h post-instillation, no corneal opacity and no iritis were observed. At this time points, slight to moderate conjunctival redness and moderate to strong chemosis and discharge were seen in all animals.
Corneal opacity was observed in 2/6 animals and was fully reversible within 48 h and 72 h, respectively.
No effects on the iris were observed in any animal at any time point.
Slight to moderate conjunctival redness was observed in all animals 24 h post-instillation. Effects were fully reversible within 48 h (2 animals), 72 h (1 animal) or 5 days (3 animals).
Slight to strong discharge was observed in all animals 24 h post-instillation. Effects were fully reversible within 72 h (5 animals) or 4 days (1 animal). - Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Table 1. Results of eye irritation study.
Rabbit # |
Time [h] |
conjunctivae |
iris |
cornea |
|
redness |
swelling |
||||
1 |
1 |
1 |
2 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
2 |
1 |
0 |
0 |
|
72 |
1 |
1 |
0 |
0 |
|
average |
1.7 |
1.0 |
0.0 |
0.0 |
|
2 |
1 |
1 |
2 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
1 |
1 |
0 |
0 |
|
average |
1.3 |
1.0 |
0.0 |
0.0 |
|
3 |
1 |
1 |
2 |
0 |
0 |
24 |
2 |
2 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
1.0 |
1.0 |
0.0 |
0.0 |
|
4 |
1 |
1 |
3 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.3 |
0.3 |
0.0 |
0.0 |
|
5 |
1 |
1 |
2 |
0 |
0 |
24 |
2 |
1 |
0 |
1 |
|
48 |
2 |
1 |
0 |
1 |
|
72 |
2 |
1 |
0 |
1 |
|
average |
2.0 |
1.0 |
0.0 |
1.0 |
|
6 |
1 |
2 |
2 |
0 |
0 |
24 |
2 |
2 |
0 |
1 |
|
48 |
2 |
2 |
0 |
1 |
|
72 |
1 |
1 |
0 |
0 |
|
average |
1.7 |
1.7 |
0.0 |
0.7 |
|
|
|
||||
Time [h] |
conjunctivae |
iris |
cornea |
||
redness |
swelling |
||||
average |
1 |
1.17 |
2.17 |
0.00 |
0.00 |
24 |
1.83 |
1.33 |
0.00 |
0.33 |
|
48 |
1.33 |
1.00 |
0.00 |
0.33 |
|
72 |
0.83 |
0.67 |
0.00 |
0.17 |
|
24+48+72 |
1.33 |
1.00 |
0.00 |
0.28 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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