Oxybispropanediol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28-31 January 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD guideline and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diglycerin

IUPAC Name:

Diglycerin

Details on test material:

- Name of test material (as cited in study report): Diglycerin
- Substance type: viscous fluid
- Physical state: liquid
- Composition of test material, percentage of components:
Glycerin 14 g/kg
Diglycerin 954 g/kg
Triglycerin 27 g/kg
the rest 5 g/kg
- Lot/batch No.: no batch number stated; sample no. 336, dated 06.01.87
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: TNO, Zeist, The Netherlands
- Age at study initiation: no data
- Weight at study initiation: 2.5-3 kg
- Housing: individually in stainless still wire cages.
- Diet (e.g. ad libitum): during acclimatization: 80g per day. During the experiment free access.
- Water (e.g. ad libitum): free access.
- Acclimation period: 13 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 70-90
- Air changes (per hr): 16x
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye of the animals was not treated and served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): not diluted

Duration of treatment / exposure:

The treated eyes of the test animals were not rinsed.

Observation period (in vivo):

24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not done


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: no information

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

All 3 rabbits showed grade 1 redness (vessels definitely injected above normal) of the conjunctivae and two of them showed some lacrimation at 1 hour after application.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an eye irritation test, performed according to OECD test guidelines, diglycerin was determined to be not irritating to the eyes of rabbits.

Executive summary:

In an eye irritation test performed according to OECD 405 and GLP, diglycerin was determined to be not irritating to the eyes of rabbits. Minimal redness of the conjunctiva was observed at 1 hour after application. No further irritating effects were observed.