[(methylethylene)bis(oxy)]dipropanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[(methylethylene)bis(oxy)]dipropanol

EC Number:

246-466-0

EC Name:

[(methylethylene)bis(oxy)]dipropanol

Cas Number:

24800-44-0

Molecular formula:

C9H20O4

IUPAC Name:

1,1'-[propane-1,2-diylbis(oxy)]dipropan-1-ol

impurity 1

Reference substance name:

Oxydipropanol

EC Number:

246-770-3

EC Name:

Oxydipropanol

Cas Number:

25265-71-8

Molecular formula:

C6H14O3

IUPAC Name:

1,1-Oxydi-2-Propanol

impurity 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

impurity 3

Reference substance name:

2-(2-(2-(2-hydroxypropoxy)propoxy)propoxy)-1-Propanol

Cas Number:

25657-08-3

Molecular formula:

C12H26O5

IUPAC Name:

2-(2-(2-(2-hydroxypropoxy)propoxy)propoxy)-1-Propanol

impurity 4

Reference substance name:

Propane-1,2-diol

EC Number:

200-338-0

EC Name:

Propane-1,2-diol

Cas Number:

57-55-6

Molecular formula:

C3H8O2

IUPAC Name:

1,2-Propanediol

Test material form:

liquid

Details on test material:

Sponsor's identification: Tripropylene glycol
Description: clear colourless slightly viscous liquid
Batch number: S-122009-310104
Purity: 99.6%
Expiry date: 14 June 2010
Storage conditions: at room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd, Hillcrest, Belton, Loughborough, UK.
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.16 - 2.34 kg
- Housing: individually in suspended cages
- Diet: 2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Once, eye closed for 1 second

Observation period (in vivo):

1hour, 24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: No effects observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hr

Remarks on result:

other: slight redness (score 1) was observed in both animals 1 hr post-instillation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hr

Remarks on result:

other: slight chemosis (score 1) was observed in both animals 1 hr post-instillation

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment.
Both treated eyes appeared normal at the 24-Hour observation.
Initial pain response upon substance instillation into the eye of the first animal was 3 by 6-point scale. Therefore one drop of local anaesthetic (Tetracaine hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of the second animal 1 to 2 minutes before treatment.

Other effects:

Both animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 1               Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex	69070 Male				69079 Male
	IPR=3				IPR=0+
Time After Treatment	1 Hour	24 Hours	48 Hours	72 Hours	1 Hour	24 Hours	48 Hours	72 Hours
CORNEA E = Degree of Opacity F = Area of Cornea Involved	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Score(ExF)x5	0	0	0	0	0	0	0	0
IRIS D	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0
CONJUNCTIVAE A= Redness B= Chemosis C=Discharge	1 1 2	0 0 0	0 0 0	0 0 0	1 1 2	0 0 0	0 0 0	0 0 0
Score (A + B + C) x 2	8	0	0	0	8	0	0	0
Total Score	8	0	0	0	8	0	0	0

IPR = Initial pain reaction

+ = One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment