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Toxicological information

Skin irritation / corrosion

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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: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation potential of the substance was evaluated in rats following exposure to 25% test concentration for 24 h.
GLP compliance:
not specified
Remarks:
This information is not available in the RAC opinion

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanoic acid
EC Number:
206-376-4
EC Name:
Decanoic acid
Cas Number:
334-48-5
Molecular formula:
C10H20O2
IUPAC Name:
decanoic acid
Details on test material:
- Name of test material (as cited in study report): Decanoic acid

Test animals

Species:
rabbit

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: PEG
Controls:
not specified
Amount / concentration applied:
approximately 27-30 mg/cm2 or 25% test concentration
Duration of treatment / exposure:
24 h
Observation period:
Daily observations for 15 d
Number of animals:
5 males and 5 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Time point:
24 h
Score:
>= 1 - < 2
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: developed into scaling and scabs (grade 1 to 2)
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Irritation was observed which was reversible within 15 d.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the study conditions, the substance was considered to be irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent decanoic acid in rats according to EU method B.3 and OECD guideline 402 in compliance with GLP. In this study, 5 male and female rats were exposed to 27 -30 mg/cm2 of 25% test substance in PEG for 24 h. Erythema grade (1 -2) irritation reactions were observed in all animals after application, which developed into scaling and scabs (grade 1 to 2). The reactions were completely reversible after 14 d of observation. Hence, under the study conditions, the substance was considered to be irriating to the skin (Talvioja, 2006, cited in ECHA RAC opinon, 2013).