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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
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.