Polyamide wax

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2000-04-04 to 2000-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K.
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 20°C
- Humidity (%): 44 to 54%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): time switch of 12 hours of artificial light (0600-1800 hours GMT) in each 24 hours period

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: each animal served as its own control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, undiluted

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 h after removal of the dressing and if relevant, daily until reversibility of reactions.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 25 mm*25mm
- Type of wrap if used: Elastoplast elastic adhesive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water (36°C) to remove residual test substance
- Time after start of exposure: 4 hours


SCORING SYSTEM: in accordance with the OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

See below table 1:
A transient well-defined erythema was observed in only one animal at 24 hours following dosing. No dermal irritation was observed in the two remaining animals throughout the observation period.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 2	Max. score: 0
24 h	0/2/0	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0/0.67/0.0	0.0/0.0/0.0
Reversibility*)	C	-
Average time (unit) for reversion	Within 48 hours	-

C: Completely reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not classified as skin irritating according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.

Executive summary:

The potential of the test item to induce skin irritation was assessed in 3 rabbits according to OECD Guideline 404 in compliance with Good Laboratory Practices.

A quantity of 0.5 g/flank was applied to a skin area under a semi-occlusive dressing for 4 hours. Skin reactions were observed 1, 24, 48, 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

After a 4-hour exposure, a well defined erythema (grade 2) was noted in one animal only 24 hours after patch removal. No dermal irritation was observed in the two remaining animals throughout the observation period.

 The mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.67, 0.0 for erythema and 0.0, 0.0; 0.0 for oedema.

It was concluded that the test item required no classification for skin irritation according to regulation (EC) n°1272/2008.