Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was compliant with the relevant guidelines and was conducted in accordance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The temperature and relative humidity recorded in the animal room were sometimes outside of the target ranges. This minor deviation was not considered to have compromised the validity or integrity of the study.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
see above
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test article name : Emulsamine AT-O
Chemical name : alkylamidoamine
Batch number: 6514
Purity: > 95 %
Origin: Feuchy plant
Expiration date of the lot/batch: july 2003
Physical state: dark brown liquid
Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- one male animal
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 3.2 kg
- Housing: polystyrene cage (48.2 cmx 58cmx 36.5cm)
- Diet : free access to 110 pelleted diet (UAR, Villemoisson, Epinay sur Orge, France)
- Water : drinking water filtered by a FG millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/ hour of filterd, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: The day before the treatment, both flanks of the animal were clipped using electric clippers and the skin of the animal was examined in order to ensure that the animal has healthy intact skin at the beginning of the study.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of the test substance were placed on a dry gauze pad.
Duration of treatment / exposure:
3-minute and 4-hour applications
Observation period:
1h and 24 h
The animal was killed on day 2 for ethical reasons.
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: right and left flank of the animal

REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wipped off by means of moistened cotton pad.

SCORING SYSTEM:
Irritation evaluated according to the grading scale originally proposed by Draize and adopted by OECD test guideline 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
other: lesion
Basis:
animal #1
Time point:
other: 1 h
Remarks on result:
other: brown coloration of the skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h
Remarks on result:
other: Necrosis
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h
Remarks on result:
other: Scoring masqued by necrosis
Irritant / corrosive response data:
After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24 hours after removal of the dressing (day 2). The animal was then killed for ethical reasons.

Any other information on results incl. tables

Since the test item showed corrosive properties on the first animal, the study was considered complete and the test item was not evaluated on other animals.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under our experimental conditions, the test substance is corrosive when applied topically to rabbits.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test substance should be classified as corrosive and assigned the symbol C, the indication of danger “Corrosive” and the risk phrase R35: “Causes severe burns”. In accordance with CLP Regulation 1272/2008, the test substance should be classified as Category 1 B corrosive substance with the signalword Danger and the hazard statement "H314: Causes severe skin burns and eye damage" associated with it.
Executive summary:

The potential of the test substance to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (96/69/EEC, B.4, 31 July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. In the first instance, the test substance was applied for a period of 3 minutes and 4 hours to a single male New Zealand White rabbit. As the test substance showed corrosive properties on this first animal, the study was considered complete and the test item was not evaluated on other animals. A single dose of 0.5ml of the undiluted test substance was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reaction were observed approximately 1 hour and 24 hours after removal of the dressing. After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24  hours after removal of the dressing (day 2) The animal was then killed for ethical reasons. Under our experimental conditions, the test substance is corrosive when applied topically to rabbits. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test substance should be classified as corrosive and assigned the symbol C, the indication of danger “Corrosive” and the risk phrase R35: “Causes severe burns”. In accordance with CLP Regulation 1272/2008, the test substance should be classified as Category 1 B corrosive substance with the signalword Danger and the hazard statement "H314: Causes severe skin burns and eye damage" associated with it.