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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
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:
Annex 1: Background document to the opinion proposing harmonised classification and labelling at Community level of octanoic acid, EC number: 204-677-5; CAS number: 124-07-2.
Author:
ECHA Committee for Risk Assessment (RAC)
Year:
2013
Bibliographic source:
CLH-O-0000002589-62-03/A1
Report date:
2013

Materials and methods

Study type:
other: Human skin ex vivo
Endpoint addressed:
skin irritation / corrosion
Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Transcutaneous Elektrical Resistance Test (TER); OECD guideline 430
Qualifier:
according to guideline
Guideline:
other: EpiDerm (reconstituted human epidermis model)

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
Constituent 2
Chemical structure
Reference substance name:
Nonanoic acid
EC Number:
203-931-2
EC Name:
Nonanoic acid
Cas Number:
112-05-0
Molecular formula:
C9H18O2
IUPAC Name:
nonanoic acid
Details on test material:
- Name of test material (as cited in study report): Nonanoic acid and Decanoic acid

Method

Type of population:
general
Subjects:
Study 1: Decanoic acid was tested in Transcutaneous Elektrical Resistance Test (TER) - a human skin ex vivo test
Study 2 and 3: Nonanoic and melted decanoic acid were tested in EpiDerm (reconstituted human epidermis model) - two in vitro tests
Ethical approval:
not specified
Route of exposure:
other: ex-vivo and in vitro tests
Reason of exposure:
other: not applicable
Details on exposure:
Decanoic acid (study 1): Transcutaneous Elektrical Resistance Test (TER) was conducted according to OECD guideline 430 following exposure to 100% test concentration for 24 h.
Nonanoic and melted decanoic acid (study 2 and 3): In vitro Epiderm skin irritation test was conducted following exposure to 100% test concentration for 15 min and 60 min respectively.

Results and discussion

Results of examinations:
Study 1: 29.9 ± 5.4 kΩ/disc (a value of ≤11 kΩ/disc indicates that a substance could produce a corrosive effect on human skin in vivo)
Study 2 and 3: Irritant; Tissue viability <50% or >50% and IL1α release 3x increased.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the two substances can be considered to be at least irritating to the skin.
Executive summary:

Standard human ex-vivo and in vitro tests were conducted to evaluate the skin irritation potential of nonanoic and decanoic acid. A transcutaneous electrical resistance test (TER) (i.e., a human ex-vivo test) was conducted with decanoic acid according to OECD guideline 430 following exposure to 100% test concentration for 24 h. As per the TER test criteria, a value of ≤11 kΩ/disc indicates that a substance could produce a corrsive effect on human skin in vivo. Under the conditions of the study, a TER of 29.9 ± 5.4 kΩ/disc indicates that the substance is not corrosive to skin. Two in vitro EpiDerm skin irritation tests were conducted with nonanoic and melted decanoic acid following exposure to 100% of the respective substances for 15 min and 60 min in reconstituted human epidermis models. The tissue viability was <50% or >50% and IL1α release 3x increased indicative of at least skin irritation potential. Overall, under the conditions of the studies, the two substances can be considered to be at least irritating to the skin (ECHA RAC opinion, 2013).