Isotridecyl isononanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experimental start date 15 April 1997. Experimental end date: 17 April 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Materials and methods

Principles of method if other than guideline:

The product was applied diluted at 10% in parafin oil just once on a surface area of about 50mm2 on the underside of the arm of cach volunteer. A dose of about 0.02ml was rubbed into a round paper filter and placed in the well of the patch.
Note: This dose was chosen because of the well's capacity as indicated by the manufacturer of "Finn Chambers".
The product was in contact with the skin for 48 consecutive hours,
At the same time, a parallel experiment was carried out with a patch-test only (none of the product was used) to serve as a negative control.
Readings
Macroscopic examinations of the skin took place immediately, 30 minutes after the patch had been removed. The assessment of skin reactions (crythema, oedema etc.) were classified under the nomenclature proposed by the linternational Contact Dermatitis Research Group (I.C.D.R.G.)

GLP compliance:

yes

Remarks:

Good clinical practice

Test material

Test material information

Constituent 1

Reference substance name:

Isotridecyl isononanoate

EC Number:

255-673-5

EC Name:

Isotridecyl isononanoate

Cas Number:

42131-27-1

Molecular formula:

C22H44O2

IUPAC Name:

Isotridecyl isononanoate

Test animals

Species:

other: Human

Details on test animals or test system and environmental conditions:

Volunteers
Characteristics of subjects
- 20 subjects were included in the experiment
- 0 were female and 20 of were male - between 19 and 48 years old.
All of the subjects must meet the inclusion criteria and did not reflect any of the cxclusion crileria.

Inclusion criteria
- no previous intolerance or allergy to a cosmetic product
- a signed written consent form

Exclusion criteria
- skin disease, regardless of location
- undergoing treatment which interscres with skin metabolism, especially isotrellinoine, tretinoine, acitretine and etretinate.

Test system

Type of coverage:

occlusive

Vehicle:

other: Parafin oil

Controls:

yes, concurrent negative control

Amount / concentration applied:

The product was applied diluted at 10% in parafin oil.
A dose of about 0.02ml was rubbed into a round paper filter and placed in the well of the patch.

Duration of treatment / exposure:

48 hours

Observation period:

48.5 hours
in the absence of any topical skin reaction after 30min, and once the dressing had been removed, the experiment is stopped. However, each volunteer must verify the lack of reaction the following day. If there is a visible reaction, the volunteer must return to the centre. In the case of any sort of clear, or dubious reaction, a reading is taken after 24 hour's and, if necessary, 72 hours after the dressing has been removed,

Number of animals:

20

Details on study design:

Readings
Macroscopic examinations of the skin took place immediately, 30 minutes after the patch had been
removed.
The assessment of skin reactions (crythema, oedema etc.) were classified under the nomenclature proposed by the linternational Contact Dermatitis Research Group (I.C.D.R.G.)

NT: Not tested
?+: Dubious reaction. Only slight erythema
+: Positive weak reaction (non vesicular): crythema, infiltration, sometimes a few papules
++: Strong positive reaction: erythema, papules or vesicles
+++: Violent positive reaction, with cysts
-: Negative reaction
IR: Irritation reaction
E 0.5: very slight erythema
E1: slight erythema
E2: moderate erythema
E3: significant erythema

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Observation

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Results table

Subject		Product Under study: PA.276/97		Negative control
Identification	Age & Sex	reading 30min after patch removal	reading 2411 after patch removal	reading 30min after patch removal	reading 2411 after patch removal
BE.FR	23 M	-	-	-	-
MA.CE	21 M	-	-	-	-
TR.CL	33 M	-	-	-	-
HO.FM	35 M	-	-	-	-
RO.FR	24 M	-	-	-	-
GR.BR	35 M	-	-	-	-
HE.MI	26 M	-	-	-	-
CR.EH	25 M	-	-	-	-
PR.MA	35 M	-	-	-	-
LA.BE	30 M	-	-	-	-
SA.NI	23 M	-	-	-	-
LA.PA	27 M	-	-	-	-
CE.ER	19 M	-	-	-	-
VA.FR	36 M	-	-	-	-
MA.CY	23 M	-	-	-	-
MO.LU	33 M	-	-	-	-
FE.RU	25 M	-	-	-	-
PU.PH	36 M	-	-	-	-
AT.PH	30 M	-	-	-	-
BO.FR	48 M	-	-	-	-

AII*	0	0	0	0
Results**	non irritant	non irritant	non irritant	non irritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under these cxpcimental conditions, no volunteers had a significant topical skin intolerance reaction at any stage during the experiment. In addition, no secondary effects were observed.
It can thus be concluded that the product, applical diluted at 10% in parasin oil topically under an occlusive dressing for 48 hours, on the skin of 20 adult volunteers was shown to be non irritant.

Executive summary:

A study was carried out of the acute skin tolerance of 20 adult volunteers using a 48 hour patch test.

The objective was to determine the primary irritant potential of a cosmetic product on a volunteer after a single application for a 48 hours period. The product was applied diluted at 10% in parafin oil.

The experiment was an open study performed on 20 subjects whose skin was free of dermatological lesions and were non allergic.

Assessment was determined on average irritation score, and the classifcation of product is based on its I.I. M.

In conclusion the average irritation of the product is equal to 0. It is thus non irritant.