AERO 5100 PROMOTER

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 Apr - 11 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17 July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

carbamothioic acid, 2-propenyl-, O-(2-methylpropyl) ester

IUPAC Name:

carbamothioic acid, 2-propenyl-, O-(2-methylpropyl) ester

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: approx. 11 - 13 weeks
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in stainless steel cages with perforated floors, hay was available on a regular basis
- Diet: STANRAB (P) SQC pellet ( Special Diet Services), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 22.5
- Humidity (%): 41 - 64
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 days
Reading time points: 1, 24, 48 and 72 h and subsequently daily up to Day 14

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 100 x 100 mm on the dorso-lumbar region
- Type of wrap: The test substance was applied to the skin under a 25 mm x 25 mm gauze pad. Each treatment site was covered with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: The treatment site was washed with warm water (39 °C) to remove any residual test substance.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 13 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 13 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Well-defined erythema with very slight to slight oedema was seen in all animals. In addition, desquamation of the stratum corneum (characterised by dryness and sloughing) developed in 2 animals. Reactions gradually ameliorated and had resolved completely in 2 animals by either Day 7 or 13. Very slight erythema and desquamation was still evident in the remaining animal at study termination on Day 14.

Other effects:

There were no signs of toxicity or ill health in any animal during the observation period.

Any other information on results incl. tables

Table 1. Results of the skin irritation study following 4 h exposure with undiluted test substance.

Observation time (Day)	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	1	0	0	0	0
2	2	1	2	2	2	2
3	2	1	2	1	2	1
4	2	1	2	2	1	1
5	2	1	2	2	1	0
6	2^D	1	2^D	2	1	0
7	2^D	1	2^D	2	0	0
8	2^D	1	2^D	1	-	-
9	2^D	1	2^D	2	-	-
10	2	1	2^D	2	-	-
11	1	1	2^D	2	-	-
12	1	1	2^D	2	-	-
13	0	0	2^D	1	-	-
14	-	-	1^D	0	-	-

D: desquamation of the stratum corneum (characterized by dryness and sloughing of the skin)

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of the Acute Dermal Irritation/Corrosion Test in rabbits the test substance does not possess any skin irritating potential.