Amides of alkyldiamine, fatty acids and carboxylic acids

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

existing in vivo study conducted in 2007

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 July 2007 to 10 August 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

impurity

Test material form:

solid: particulate/powder

Details on test material:

The test material is a UVCB substance.

Specific details on test material used for the study:

Identification AD-2000
Form White powder
Batch L-620150
Storage At room temp in the dark
Stability under storage condition Stable
Expiry date 1 January 2009

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test animals: Albino rabbit, New Zealand White, (SPF-Quality
Number of animals: 3 males
Age and body weight: Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.

Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0°C (actual range: 21.2 - 22.6°C}, a relative humidity of 30-70% (actual range: 45- 75%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.

Accommodation
Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm).
Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

Diet
Pelleted diet for rabbits (K-H from SSNIFF® Spezialdiaten GmbH, Soest, Germany) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.

Water
Free access to tap water.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: watery ethanol

Controls:

not required

Amount / concentration applied:

0.5 gm of test substance in 0.6 ml of vehicle

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters
(1Ox15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.

Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.6 ml of the vehicle and applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape#, which was wrapped around the abdomen and secured with Caban elastic bandage.
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 24h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin irritation was caused by the 4 hour exposure to the test substance

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance did not cause any skin irritation when 3 white rabbits were exposed to it for 4 h. Not classified as a skin irritant.