Polyamide wax

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 23rd 2005 to September 2nd 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviation from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines (2000) including the most recent partial revisions

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: EA-3098
CAS number: 55349-01-4
Description: white powder
Batch: P-32681
Purity: not indicated by the sponsor, treated as 100% pure
Storage: room temperature in the dark
Stability under storage conditions: Stable
Expiry date: June 6th 2009

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44 x 37.5 cm)
- Diet: Approximately 100 g per day of standard laboratory diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany).
- Water: ad libitum access to tap water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C +/- 3°C (actual range: 20.2 - 22.3°C)
- Humidity (%): 30 - 70% (actual range: 40 - 77%)
- Air changes (per hr): Approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped free of fur

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with watery ethanol (50% v/v) immediatley before application, to ensure close contact with the animals skin.

Duration of treatment / exposure:

4 h

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

STUDY DESIGN:
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 7 days later, after considering the degree of skin irritation observed in the first animal.

TREATMENT:
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10 x 15 cm2). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.

Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 1 ml watery ethanol (50% v/v) and applied to the skin of one flank, using a metalline patch of 2 x 3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.

After the final observation, the animals were sacrificed by intra-venous injection of pentobarbital.

OBSERVATIONS:
Mortality/Viability: Twice daily
Toxicity: At least once daily
Body weight: Day of treatment (prior to application) and at termination.
Irritation: The skin reactions were assessed at appromixmately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

( Animal 754)

Time point:

other: Mean of scores at 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: No effects observed

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(Animal 744)

Time point:

other: Mean of scores at 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(Animal 751)

Time point:

other: Mean of scores at 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

(Animal 754)

Time point:

other: Mean of scores at 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

(Animal 744)

Time point:

other: Mean of scores at 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

(Animal 751)

Time point:

other: Mean of scores at 24, 48 and 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Irritant / corrosive response data:

No skin irritation was caused by 4 hours exposure to EA-3098.

Other effects:

No staining of the treated skin by the test substance was observed and no test substance remnants were seen.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

No skin irritation was caused by 4 hours exposure to EA-3098. Based on the results of the study EA-3098 does not have to be classified for skin irritation.

Executive summary:

A skin irritation/corrosion study with EA-3098 in the rabbit (4 -hour semi-occlusive application) was conducted according to the following guidelines:

- OECD 404 "Acute Dermal Irritation/Corrosion" (2002)

- EC, Council Directive 67/548/EEC, Annex V, B.4 (2004) "Acute Toxicity: Dermal Irritation/Corrosion"

- US EPA OPPTS 870.2500 (1998) Acute Dermal Irritation

- JMAFF Guidelines (2000) including the most recent partial revisions

Three rabbits were exposed to 0.5 grams of EA-3098, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4 hours exposure to EA-3098.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Based on these results, EA-3098 does not have to be classified as a skin irritant as it does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation (CLP).