Dodecyl 5-oxo-L-prolinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

no reading at 48h

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Method described to the official journal of French Republic (Offical Journal of 21 february 1982)

Deviations:

yes

Remarks:

physical state not specified (SDS mentions "waxy solid"). No reading at 48h. Study stopped at 72h. The quantity of substance applied is not clearly indicated.

Principles of method if other than guideline:

This method is used to evaluate the index of Primary Irritation induced by a test article, after a single application
Any substance provoking after a single applciation an orthoergic inflammatory cutaneous reaction appearing within 24 hours on the application site is designated as a Primary irritant.

GLP compliance:

no

Remarks:

GLP not mandatory at this date

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl 5-oxo-L-prolinate

EC Number:

245-224-1

EC Name:

Dodecyl 5-oxo-L-prolinate

Cas Number:

22794-26-9

Molecular formula:

C17H31NO3

IUPAC Name:

dodecyl 5-oxo-L-prolinate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: "Elevage scientifiques des dombes, C.E.G.A.V"
- Age at study initiation: Not specified
- Weight at study initiation: 2.5 to 3 kg
- Housing: 1 animal by cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least 1 week before treatment
- Sex : males
- Number of animals : 6

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): 3 000 m3/hr
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Type of coverage:

not specified

Preparation of test site:

other: one flank shaved and abraded and the other flank only shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of product or 0.5 g as solid. Information not specified in report.

Duration of treatment / exposure:

24 hours

Observation period:

at 24 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 3x3 cm square patchs
- Type of wrap if used: Adhesive bandage

REMOVAL OF TEST SUBSTANCE : the fixing bandage is removed at 24 hours
- Washing (if done): no

OBSERVATION TIME POINTS: at 24 hours and 72 hours

SCORING SYSTEM:
- Method of calculation: primary dermal irritation index

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: For all animals and areas (normal and scarified)

Time point:

24 h

Score:

<= 2

Max. score:

2

Results 2

Irritation parameter:

erythema score

Basis:

other: For all animals and areas

Time point:

48 h

Remarks on result:

other: no reading at 48h

Results 3

Irritation parameter:

erythema score

Basis:

other: For all animals and areas (normal and scarified)

Time point:

72 h

Score:

<= 2

Max. score:

2

Results 4

Irritation parameter:

edema score

Basis:

other: For all animals and areas (normal and scarified)

Time point:

24 h

Score:

<= 2

Max. score:

2

Results 5

Irritation parameter:

edema score

Basis:

other: For all animals and areas

Time point:

48 h

Remarks on result:

other: no reading at 48h

Results 6

Irritation parameter:

edema score

Basis:

other: For all animals and areas (normal and scarified)

Time point:

72 h

Score:

<= 2

Max. score:

2

Irritant / corrosive response data:

At 72 hours, the following observation have been done :
The maximum score at each reading time for all animals and areas (normal and scarified), is max 2.0 for erythema and oedema at 24 and 72 hours (reading time).
Desquamation is important in 3, moderate in 2 and slight in 1 non scarified animals.
Moreover, skin flexibility is slightly alterated in one animal, moderatly in two animals and severly in three animals.

Other effects:

NB: no reading at 48h

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Lesions observed following the application of the product according to the protocol described are erythematous type with oedematous lesions in all animals. The classification scoring of 2.3 is not reached. Therefore, under tests conditions, the test item does not require a classification according to GHS criteria.