N-(1-oxooctyl)glycine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

july to august 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: complete study according to GLP guidelines and OECD 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(1-oxooctyl)glycine

EC Number:

238-122-3

EC Name:

N-(1-oxooctyl)glycine

Cas Number:

14246-53-8

Molecular formula:

C10H19NO3

IUPAC Name:

N-(1-oxooctyl)glycine

Constituent 2

Reference substance name:

LCA07012

IUPAC Name:

LCA07012

Details on test material:

Sponsor’s identification: LCA07012
• Date received : 24 & 27 July 2007
• Container : plastic flask (n=3)
• Form : powder
• Quantity : 726.0 g (container + contents)
• Colour : white
• Batch n° : 0716300006 • Storage : room temperature
• Production date: 12 June 2007
• Expiry date: 11 June 2010 (re-test)
• Purity: 99%
It was identified under the code number: PH-07/0301.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste –
F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the
animals weighed between 2.18 kg and 2.52 kg.

Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19°C and 23°C
- relative humidity : between 49% and 66%
- lighting time: 12 hours daily

Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The test item was applied, as supplied, at a dose of 0.5 g, on an undamaged skin area of one flank of
each animal

Duration of treatment / exposure:

The skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the test item.

Observation period:

until 72hrs

Number of animals:

3 animals was treated

Details on study design:

The patch was moistened and secured in position with a strip of surgical adhesive tape.
After the removal of the patch, the treated area was rinsed with distilled water.
On the opposite flank, an untreated area was served as the control.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritant / corrosive response data:

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24,
48 and 72 hours).

Other effects:

none

Any other information on results incl. tables

none. not irritant for skin

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24,
48 and 72 hours).The results obtained, under these experimental conditions, enable to conclude that the test item
LCA07012 according to the scales of interpretation retained:
- is non irritant to skin (PSi = 0) according to the classification established in the Journal Officiel de
la République Française dated February 21st, 1982,
- and, need not to be classified, according to the criteria for classification, packaging and labelling of
dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and
99/45. No symbol and risk phrase are required.

Executive summary:

The test item LCA07012 was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C.D. guideline n° 404 dated April 24th, 2002 and the test method B.4 of the directive n° 2004/73/EC. No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours). The results obtained, under these experimental conditions, enable to conclude that the test item LCA07012 need not to be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.