N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23. Feb - 3 March 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed and reported study equivalent to OECD guideline 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 h exposure (more rigid test conditions than required by OECD guideline)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: proposed guideline of the US EPA paragraph 163.81-5 "Primary Dermal Irritation Study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Deviations:

no

GLP compliance:

no

Remarks:

performed before GLP guidelines

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide

EC Number:

279-979-3

EC Name:

N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide

Cas Number:

82493-14-9

Molecular formula:

C28H40N2O3

IUPAC Name:

N-(2-ethoxyphenyl)-N'-[4-(10-methylundecyl)phenyl]ethanediamide

Details on test material:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Füllinsdorf, Switzerland
- Age at study initiation:12-16 weeks
- Weight at study initiation: 2.3-3.0 kg
- Housing:individual in stainless steel cages
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-2°C
- Humidity (%): 55+/-10%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 h

Observation period:

24, 48, 72 h, 4 and 7 days

Number of animals:

3 males, 3 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h/48h/72/h

Score:

0

Max. score:

4

Remarks on result:

other: no effects

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

0

Max. score:

4

Remarks on result:

other: no effects

Irritant / corrosive response data:

The rest item showed no irritation, no acute toxicological signs were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With reference the absence of any(skin) effects Hostavin 3206 has not to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Executive summary:

Hostavin 3206 was tested for its skin irritant properties in 6 New Zealand White rabbits. The study was performed equivalent to OECD Guideline 404. The only deviations was a prolonged exposure period (24 hours). These conditions make the study design more rigid compared to the regarding OECD Guideline. No effects on the skin (erythema and edema) were observed in all animals at any observation time after application.

With reference the absence of any (skin) effects Hostavin 3206 has not to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).