Ethanol, 2-ethoxy-, manufacture of, by-products from

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

29 Jan 1974 - 06 Feb 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report which meets basic scientific principles. Rationale for using a read across substance is included in summary record for this end point.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

, only two rabbits used. 20 hours exposure.

Principles of method if other than guideline:

Method: BASF-Test: Two animals were treated for 1, 5, 15 minutes and for 20 hours using occlusive conditions. An application site was covered with the liquid test substance. The animals were observed 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

EC Number:

203-962-1

EC Name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

Cas Number:

112-35-6

Molecular formula:

C7H16O4

IUPAC Name:

2-[2-(2-methoxyethoxy)ethoxy]ethanol

Details on test material:

- Name of test material (as cited in study report): Methyltriglykol. Test substance No. 88/289
- Physical state: liquid
- Analytical purity: ca. 95%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.63 kg (mean)

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

no data

Duration of treatment / exposure:

1 min, 5 min, 15 min, 20 h

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done including time after start of exposure: After the application times (1, 5 and 15 min) the skin was washed with Lutrol (100%) and Lutrol solution (50%).

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 20 hours exposure time

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: 20 hours exposure time

Any other information on results incl. tables

Mean erythema score after 24, 48 and 72 h (animal1/animal2)

Exposure time	24h	48h	72h	mean
1min	0/0	0/0	0/0	0/0
5min	0/0	0/0	0/0	0/0
15min	0/0	0/0	0/0	0/0
20h	1/1	0/0	0/0	0.3/0.3

At the end of the observation period after 8 days no erythema were found.

Mean edema score after 24, 48 and 72 h (animal1/animal2)

Exposure time	24h	48h	72h	mean
1min	0/0	0/0	0/0	0/0
5min	0/0	0/0	0/0	0/0
15min	0/0	0/0	0/0	0/0
20h	0/0	0/0	0/0	0/0

At the end of the observation period after 8 days no edema were found. The test subsstance was not irritating.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In a well reported skin irritancy study, the test substance 2-(2-(2-methoxyethoxy)ethoxy)ethanol was applied under occluded conditions to rabbit skin for exposure periods of up to 20 hours. The test substance was then washed before observing the animals for a period of up to 8 days. Mild erythema was seen in one of the two test animals but odema was not reported. Effects disappeared within 48 hours. On the basis of these results the substance is not regarded as a skin irritant.