(ethylenedioxy)dimethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No details about the test substance

GLP compliance:

yes (incl. QA statement)

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, D 2740 Bremervörde
- Housing: individual
- Diet (e.g. ad libitum): Certified diet (periodically analysed for contaminations)
- Water (e.g. ad libitum): tap water (periodically analysed for contaminations)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin area of the same animal served as control

Amount / concentration applied:

0.5 ml of the test substance applied to ca. 6 cm² test site

Duration of treatment / exposure:

4 h

Observation period:

15 days

Number of animals:

3

Details on study design:

Examination time points: 0-60min, 24 h, 48 h, 72 h after patch removal and thereafter once daily up to day 15. Scoring system as described in OECD 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: the end of observation period (day 15).: score 1

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: At the end of observation period (day 15): score 1 for 2 out of 3 rabbits

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substacne is a skin irritant. But effects are not completely reversible within 15 days.

In conclusion, classification as irritating is indicated according to Regulation (EC) No 1272/2008: H315 - Causes skin irritation.

Executive summary:

The test was performed according to OECD guideline 404. Three New Zealand rabbits were used; 0.5 ml of the undiluted test substance were applied to the skin; semiocclusive, 4 h exposure; post exposure observation period 15 days. The average score (24-72h) for erythema and edema was 1.2 and 1.3 respectively. The effects for edema was not fully reversible after 15 d.