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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
June 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
- Principle of test: Single dose applied
- Short description of test conditions: 2 New Zealand white rabbits each received a single dermal application of 0.5 mL of the appropriate test article on two sites, one abraded and one intact.
- Parameters analysed / observed: erythema, edema and other effects 24 and 72 hours after application.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
EC Number:
268-581-5
EC Name:
Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
Cas Number:
68130-24-5
Molecular formula:
C10-H22-O7.x-C10-H20-O2.x-C8-H16-O2.x-C5-H10-O2
IUPAC Name:
Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
Test material form:
liquid
Details on test material:
- Moisture content:<= 0.05 %
Specific details on test material used for the study:
Lot n° P-133L4

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
other: corn oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 10% in corn oil

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
2
Details on study design:
2 New Zealand white rabbits, each received a single dermal application of 0.5 mL of the appropriate test article on two sites, one abraded and one intact. The test sites were occluded for 24 hours and were observed individually for erythema, edema, and other effects 24 and 72 hours after application.
Mean score from the 24 and 72 hour readings were averaged to determine the primary irritation index. Thes test articles were used as received.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.63
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.63
Reversibility:
not specified
Remarks on result:
probability of weak irritation

Applicant's summary and conclusion

Conclusions:
Results : slightly irritant to the skin with primary irritation index = 0.63.