2-(2,6-diethyl-4-methyl-phenyl)propanediamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 August 2003 to 17 August 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

452-330-3

EC Name:

-

Cas Number:

314020-40-1

Molecular formula:

C14H20N2O2

IUPAC Name:

2-(2,6-diethyl-4-methyl-phenyl)propanediamide

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: Powder, yellowish
- Storage condition of test material: In the dark at ambient temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2517-3466 g
- Housing: Individually
- Diet: ad libitum
- Water: ad libitum mains water
- Acclimation period: A minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 changes minimum
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial), 12 hours dark

IN-LIFE DATES: From: 5 August 2003 To: 17 August 2003

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL of deionised water to form a dry paste to allow good skin contact.

Duration of treatment / exposure:

4 hours

Observation period:

3 days post administration

Number of animals:

1 male, 2 females (3 animals in total)

Details on study design:

TEST SITE
- Area of exposure: On the day prior to application, the hair was removed with a pair of veterinary clippers from an area approximately 7 cm x 13 cm on the left flank of each animal. The test material was moistened to a dry paste with 0.5 mL deionised water and applied with a metal spatula to the test site with an approximate size of 2.5 cm x 2.5 cm.
- Type of wrap if used: The treated area was covered with a piece of 4-ply surgical gauze (approximate size 2.5 cm x 2.5 cm) which was secured by two strips of surgical tape (approximate size 1 cm x 8 cm). This was covered by a piece of impermeable rubber sheeting (approximate size 35 cm x 13 cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the dressing was carefully removed using blunt-tipped scissors and the application site was gently cleansed of any residual test material using clean swabs of absorbent cotton wool soaked in clean warm water and then dried gently with clean tissue paper.
- Time after start of exposure: approximately 4 hours

SCORING SYSTEM:
The Draize scale (Draize 1959), presented as table 1 in the field "Any other information on material and methods incl. tables" was used to assess the degree of erythema and oedema at the application sites approximately 1 hour and 1, 2 and 3 days after the removal of the dressings. Any other signs of skin irritation were also noted.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 day

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 day

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 day

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema was seen in all animals approximately 1 hour after application and very slight erythema was seen in one animal at the same time. There were no other signs of skin irritation. All irritation scores are presented in table 2 in the field "Any other information on results incl. tables".

Other effects:

There were no signs of ill-health in any animal during the study.

Any other information on results incl. tables

Table 2: Erythema and Oedema Scores

Animal No.	Erythema					Oedema
	Time after decontamination				Mean Score	Time after decontamination				Mean Score
	1 hour	1 day	2 days	3 days		1 hour	1 day	2 days	3 days
76 (M)	1	0	0	0	0.0	1	0	0	0	0.0
103 (F)	1	0	0	0	0.0	0	0	0	0	0.0
104 (F)	1	0	0	0	0.0	0	0	0	0	0.0

The mean values have been calculated using the day 1, 2 and 3 values.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The skin irritation of the test material was determined in accordance with the standardised guidelines OECD 404, EU Method B.4 and EPA OPPTS 870.2500. Three rabbits received a single four hour application of 0.5 g of the test material and were assessed for the following 3 days for any signs of skin irritation. Very slight erythema was seen in all animals approximately one hour after application and very slight oedema was seen in one animal at the same time. There were no other signs of skin irritation.

Under the conditions of the study, the test material is considered to be practically non-irritating to the skin based on an internal system for description of irritation responses. The test material does not require classification for skin irritation in line with Regulation No. 1272/2008.