(ethylenedioxy)dimethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(Version Feb. 1987)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(ethylenedioxy)dimethanol

EC Number:

222-720-6

EC Name:

(ethylenedioxy)dimethanol

Cas Number:

3586-55-8

Molecular formula:

No exact molecular formula can be given for a complex reaction mixture (UVCB substance).

IUPAC Name:

[2-(hydroxymethoxy)ethoxy]methanol

Test animals / tissue source

Species:

rabbit

Strain:

other: Little Russian

Details on test animals or tissues and environmental conditions:

Source: BI Phrama KG, D88397 Biberach
Sex: female
Age/weight at study initiation: 2.9 kg
Housing: individual housing
Certified diet and tape water (periodically analysed for contaminations).


Photoperiod (hrs dark / hrs light): 12 h light and 12 h darkness,
Relative humidity: 40-70%,
Temperature: 17-23°C

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

Up to 28 days

Number of animals or in vitro replicates:

1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

not reversible

Remarks on result:

other: Cornea opacity score (7d - 28 d): 4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 0 - <= 3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

>= 1 - <= 4

Results 5

Irritation parameter:

other: discharge

Basis:

animal #1

Time point:

other: 7 d - 28 d

Score:

>= 2 - <= 3

Reversibility:

not reversible

Any other information on results incl. tables

Cornea Serious damage, not reversible

Iris Score 1 but scoring not possible at some readings

Conjunctiva

Redness Highest scores observed at several readings

Chemosis Highest scores observed at several readings

Discharge Highest scores observed at several readings, not reversible

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The test substance causes serious damage to the eye which was not reversible.
Classification as eye damaging is indicated according to Regulation (EC) No 1272/2008: H318 - Causes serious eye damage.

Executive summary:

In a test according to OECD guideline 405 the eye irritating portential of the test item was determined. 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of one female rabbit. Readings were performed at 1, 24, 48, 72 h, 7 days, 14 days, 21 days, and 28 days after instillation. The test substance causes serious damage to the eye which was not reversible.