3,6,9,12-tetraoxotridecanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Scientifically reliable study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,6,9,12-tetraoxotridecanol

EC Number:

245-883-5

EC Name:

3,6,9,12-tetraoxotridecanol

Cas Number:

23783-42-8

Molecular formula:

C9H20O5

IUPAC Name:

2,5,8,11-tetraoxatridecan-13-ol

Test material form:

liquid

Details on test material:

- Physical state: colorless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Box reason, conventional breeding
- Age at study initiation: 3 - 5 Months
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: in a fully air-conditioned rooms in individual cages (Battery cages)
- Diet: Altromin 2123 maintenance diet - rabbit Altomin GmbH, Lage / Lippe, ad libilum and hay (approximately 15g per day)
- Water: deionized, chlorinated water from automated watering ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20%
- Photoperiod: 12 hours a day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5 ml of the undiluted substance.

Duration of treatment / exposure:

4 hours.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Approximately 24 hours prior to the experiment start 3 rabbits in the dorsal region were of trunk with an electric hair clipper with an area of approximately 25 cm2 depilated. Only animals with intact skin were used.
- Type of wrap if used: Each animal was given a wound plaster with 2.5 x 2.5 cm coarse pulp edition (special design the company, Beiersdorf AG, Hamburg) were prepared and fixed on the skin site. Area was then covered with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remaining was test substance was gentlyremoved with tap water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Individual animal data are not reported as there were no effects seen from 24 hour observation and beyond

Any other information on results incl. tables

One hour after removal of the patch was barely visible on two animals. Erythema observed. 24 hours after the administration no symptoms of irritation were observed.

Time after removal of patch	1 hr	24hr	48hr	72hr
Animal number	1 2 3	1 2 3	1 2 3	1 2 3
Erythema and Eschar	1 1 0	0 0 0	0 0 0	0 0 0
Oedema	0 0 0	0 0 0	0 0 0	0 0 0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In a guideline skin irritation study, the substance methyl tetraglycol caused no irritation over the observation period 24 -72 hours following application of the substance.