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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid without restriction. Well documented GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
EPA Guideline 81-5
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,18-octadecanedioic acid
EC Number:
442-490-2
EC Name:
1,18-octadecanedioic acid
Cas Number:
871-70-5
Molecular formula:
C18H34O4
IUPAC Name:
octadecanedioic acid
Constituent 2
Reference substance name:
Octadecanedioic acid
EC Number:
617-978-5
IUPAC Name:
Octadecanedioic acid
Test material form:
solid: flakes
Details on test material:
Purity: 100% active matter
Remarks: White, solid.
Solubility: Poorly soluble (=< 2 mg/L in test medium).
Carbon chain length distribution: C16 2,98%, C18 92,9%, C18:1 1,04%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
4 hours
Observation period:
The skin was examined at 0.5, 24, 48, and 72 hours after removal of the patches.
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 4.5, 24, 48 and 72 h score average
Score:
0

Any other information on results incl. tables

Rabbit No.

 

0.5

hrs

24

hrs

48 hrs

72

hrs

599

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

600

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

601

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

602

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

603

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

604

Erythema-Eschar

Edema

0

0

0    

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Primary dermal irritation index (4.5, 24, 48 and 72 h score average) was 0. Not irritating.