Registration Dossier

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: National guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

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

Constituent 1
Chemical structure
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
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: crystalline solid substance
- Analytical purity: no data

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:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72-96 h
Remarks on result:
other: individual mean scores ranged between 0.0 and 1.0
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 48 h - 6 days
Remarks on result:
other: individual mean scores ranged between 0.3 and 2.0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h - 6 days
Remarks on result:
other: individual mean scores ranged between 0.3 and 1.7
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
score

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified