2-Butyne-1,4-diol, polymer with methyloxirane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report which meets basic scientific principles with acceptable restrictions (limited documentation, e.g. no details about test substance)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Principles of method if other than guideline:

Skin irritation was tested using an internal standardized test method (BASF test).
White Vienna rabbits were used. Usually, two animals were treated for 1, 5, 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application times (1, 5 and 15 min) the skin was washed with Lutrol solution (50%). The animals were observed for 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:

Hydroxyethylated 2-butyne-1,4-diol

EC Number:

608-711-3

Cas Number:

32167-31-0

Molecular formula:

C4 H6 O2 (C2 H4 O) n, where 1 < n < 4.5

IUPAC Name:

Hydroxyethylated 2-butyne-1,4-diol

Details on test material:

- Name of test material (as cited in study report): Golpanol BEO = Golpanol SC 9189
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.45 kg (male 1), 2.64 kg (male 2)

ENVIRONMENTAL CONDITIONS
- not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): presumably 1 mL

Duration of treatment / exposure:

1 min, 5 min, 15 min and 20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

TEST SITE
- Area of exposure: The application site of 2.5 X 2.5 cm at the upper third of the back was covered with a cotton cloth loaded with the undiluted liquid (37°C; approx. 1 mL)

REMOVAL OF TEST SUBSTANCE
- Washing: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50% (mild detergent) was used.
No washing was done after the 20 hours treatment.

SCORING
Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(20-hour application)

Basis:

mean

Remarks:

out of 2 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: There are no data about 72 h. Due to not any irritating effects at 24 and 48 hour reading time point, the value for the 72 hour reading time point was extrapolated and considered to be 0.

Results 2

Irritation parameter:

edema score

Remarks:

(20-hour application)

Basis:

mean

Remarks:

out of 2 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: There are no data about 72 h. Due to not any irritating effects at 24 and 48 hour reading time point, the value for the 72 hour reading time point was extrapolated and considered to be 0.

Irritant / corrosive response data:

After 20 hours treatment no irritant effects were determined at reading times of 24, 48 hours and the end of the observation period of 6 days.

Other effects:

No other effects observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
EU: not classified

Executive summary:

Skin irritation was tested using an internal standardized test method (BASF test).

Two white Vienna rabbits were treated for 1, 5, 15 minutes and for 20 hours using occlusive conditions. A shaved application site of 2.5x2.5 cm was covered with the liquid test substance. After the application times (1, 5, 15 min and 20 hours) the skin was washed with Lutrol solution (50%). The animals were observed for 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. There are no data about 72 h. Due to not any irritating effects at 24 and 48 hour reading time point, the value for the 72 hour reading time point was extrapolated and considered to be 0. After 20 hours treatment no irritant effects were determined at reading times of 24, 48 hours and the end of the observation period of 6 days.

According to the conditions of the test, the test substance has not to be classified as irritant to the skin.