4,7-Decanediol, 2,4,7,9-tetramethyl-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4,7,9-tetramethyldecane-4,7-diol

EC Number:

451-160-7

Cas Number:

17913-76-7

Molecular formula:

C14H30O2

IUPAC Name:

2,4,7,9-tetramethyldecane-4,7-diol

Constituent 2

Reference substance name:

2,4,7,7-Tetramethyl-4,7-decanediol

IUPAC Name:

2,4,7,7-Tetramethyl-4,7-decanediol

Details on test material:

YBC-34B-003//P001, Lot number 18197-D-5
Purity: 99 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

#1: 3 minutes 0,5 ml one animal
#2: 1 hour 0,5 ml three animals
#3: 4 hour 0,5 ml three animals

Observation period:

14 days

Number of animals:

three animals

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

F8931, F8941, F8962

Time point:

other: day 14

Score:

ca. 2.17

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

other: normal

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not classified as irritating to skin.

Executive summary:

3 Minute exposure: There was no erythema or edema noted at 1 hour following patch removal.

1 hour exposure: Erythema was absent to barely perceptible at 1 hour following patch removal, barely perceptible at 24 hours. absent to barely perceptible at 48 hours, and absent to well defined at 72 hours. Erythema was absent by day 7 and 14. Edema was absent at 1 hour following patch removal and absent to barely perceptible at 24 hours. Edema was absent at 48 and 72 hours, and on days 7 and 14.

4 hour exposure: Erythema was barely perceptible at 1 hour following patch removal and barely perceptible to well defined at 24, 48, 72 hours. Erythema was absent on days 7 and 14. Edema was absent at 1 hour following patch removal, barely perceptible at 24 hours, and absent to barely perceptible at 48 and 72 hours. Edema was absent on days 7 and 14.

Systemic Observations: There were no abnormal physical signs noted during the observation period. All body weight changes were normal.