Dodecanoic acid, ester with oxybis[propanediol]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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)

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 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: animales were housed individually
- 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(s) applied (volume or weight with unit): 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 from 0 to 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 from 0.3 to 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 from 0.3 to 1.7

Irritant / corrosive response data:

At the 1, 2 and 8 h reading time points, no corneal opacity and no iritis were observed in any animal. Whereas at this time points, slight to moderate conjunctival redness and moderate to strong chemosis and discharge were seen in all animals (see Table 2 under “Any other information on results incl. tables”). In 2/6 animals corneal opacity was observed and was fully reversible within 48 h and 72 h, respectively.
No effects on the iris were observed in any animal during the study period.
Slight to moderate conjunctival redness was observed in all animals 24 h post-instillation being fully reversible within 48 h (2 animals), 72 h (1 animal) and 5 days (3 animals).
24 h post application, slight to strong discharge was observed in all animals. Effects were fully reversible within 72 h in 5 animals and 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 number #	Time [h]	conjunctivae score		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 score		iris	cornea
		redness	swelling
average scores	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