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Toxicological information

Skin irritation / corrosion

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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report date:
1966

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 2 animals were treated for 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal / lateral flank of the back.

After the application time, the skin was washed with water which sometimes contained a mild detergent.

The animals were observed for 8 days and skin changes were recorded on working days.

The report usually describes findings after 24 hours and at the end of the observation period. Thus, for final evaluation, the findings after 48 and 72 hours from the raw data have to be taken into account.

The original BASF grading was converted into the numerical grading according to the OECD Draize system.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,6,9,12-tetraoxahexadecan-1-ol
EC Number:
216-322-1
EC Name:
3,6,9,12-tetraoxahexadecan-1-ol
Cas Number:
1559-34-8
Molecular formula:
C12H26O5
IUPAC Name:
3,6,9,12-tetraoxahexadecan-1-ol
Details on test material:
- Name of test material (as cited in study report): Butyltetraglykol, Tetraäthoxybutanol
- Molecular formula (if other than submission substance): C4H9(OC2H4)4-OH
- Physical state: liquid
- Analytical purity: 90%

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 1 ml
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2 animals (one male and one female)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Reversibility:
other: no adverse reaction seen
Irritant / corrosive response data:
no clinical signs visible after 24 hours or 8 days on dorsal skin;
(slight redness visible after 24 hours on the skin of the ear, which was totally recovered after 8 days)

Any other information on results incl. tables

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

Incubation time

24 hours after application

8 days after application

Animal 1

Animal 2

Animal 1

Animal 2

1 min

5 min

15 min

20 hours

0

0

0

0

Draize Dermal Irritation Scoring System:

Erythema and Eschar Formation

Value

Edema Formation

Value

No  erythema

Very slight erythema (barely perceptible)

Well defined  erythema

Moderate to severe  erythema

Severe  erythema (beet-redness) to slight, eschar formation (injuries in depth)

0

1

2

3

4

No  edema

Very slight edema (barely perceptible)

Slight edema (edges of area well defined by definite raising)

Moderate edema (raised approx. 1 mm)

Severe  edema (raised more than 1 mm and extending beyond the area of exposure)

0

1

2

3

4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

An old but well reported skin irritation study is available. This study followed the basic principles of the current OECD guideline. White Vienna rabbits were used. 2 animals were treated for 20 hours of dermal exposure to the substance 3,6,9,12-tetraoxahexadecan-1-ol under occlusive conditions. No adverse skin reaction was seen. On this basis, the substance does not warrant classification as a skin irritant.