2,3-dihydroxypropyl laurate

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: 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

Test material information

Constituent 1

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 dodecanoate

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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