α-hydroxy-β,β-dimethyl-γ-butyrolactone

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: Guideline study but without GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

α-hydroxy-β,β-dimethyl-γ-butyrolactone

EC Number:

209-963-3

EC Name:

α-hydroxy-β,β-dimethyl-γ-butyrolactone

Cas Number:

599-04-2

Molecular formula:

C6H10O3

IUPAC Name:

(3R)-3-hydroxy-4,4-dimethyloxolan-2-one

Details on test material:

- Name of test material (as cited in study report): D-Pantolacton kristallin
- Physical state: solid white crystals
- Analytical purity: >99 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: mean weight females 3.50 kg; male 3.59 kg
- Housing: in cages made of stainless steel with wire mesh walk floors; floor area 40 cm x 51 cm
- Diet: Kliba 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of the same animal served as control

Amount / concentration applied:

0.1 ml bulk volume (about 37 mg of the comminuted test substance)

Duration of treatment / exposure:

the substance was not washed out

Observation period (in vivo):

9 days

Number of animals or in vitro replicates:

3 animals, 2 females and 1 male

Details on study design:

- Application site: single application to the conjunctival sac of the right eyelid
- Reading time points: 1h, 24h, 48h, 72h and 9d after application

SCORING SYSTEM: according to OECD TG 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 9 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 9 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 9 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Any other information on results incl. tables

Table 1: Results acute eye irritation for the individual animals:

Readings	Animal	Cornea	Iris	Conjunctiva redness	Conjunctiva chemosis	Symptoms
1 h	1	0	0	2	1
	2	0	0	2	2
	3	0	0	2	2
24 h	1	1	1	2	2	pupil contracted
	2	1	0	2	2
	3	1	0	2	2
48 h	1	1	1	2	1
	2	1	0	2	1
	3	1	0	2	1
72 h	1	1	0	2	1
	2	1	0	2	1
	3	1	0	2	1
9 d	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0