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

Endpoint summary

Description of key information

Skin irritation was tested in a study according to OECD guideline 404 in rabbits. No effects on the skin (erythema and edema) were observed

in all animals at any observation time after application.
Hostavin 3206 was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. No effects were observed in all animals 24, 48 and 72 hours after application.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

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)

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

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h/48h/72/h

Score:

0

Max. score:

4

Remarks on result:

other: no effects

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.

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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 405.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

4 days acclimatisation

Qualifier:

according to guideline

Guideline:

other: proposed guidelines of the US EPA paragraph 163.81-4 "Primary Eye Irritation Study", Federal Register, Vol. 43, No. 163, Aug. 22, 1978

Deviations:

no

GLP compliance:

no

Remarks:

performed before GLP guidelines

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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: individually in stainless steel cages
- Water (e.g. ad libitum): ad libitum
- Diet: Standard Kliba 341 Rabbit Maintenance Food, Klingentalmühle AG, Switzerland
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

no washing performed

Observation period (in vivo):

24, 48, 72 h, 4, 7, 14 and 21 days

Number of animals or in vitro replicates:

3

Details on study design:

A single dose of the test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and th lids were gently closed for a few seconds. The right eye remained untreated and served as a control. In 3 out of 6 rabbits approx. 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

0

Max. score:

80

Remarks on result:

other: no effects

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

0

Max. score:

10

Remarks on result:

other: no effects

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h/48h/72h

Score:

0

Max. score:

20

Remarks on result:

other: no effects

Irritant / corrosive response data:

no effects observed

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With reference the reported scores (absence of effects) Hostavin 3206 does not have to be classified as irritant to the eyes 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 eye irritant properties in 6 New Zealand White rabbits.The study was performed equivalent to OECD Guideline 405.No effects were observed in all animals 24, 48 and 72 hours after application.

With reference the reported scores (absence of effects) Hostavin 3206 does not have to be classified as irritant to the eyes 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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Endpoint summary “irritation/corrosion”

Skin irritation: 1 key study available: not irritating

Eye irritation: 1 key study available: not irritating

 

There is one reliable study on the skin irritancy potential. Skin irritation was tested in a guideline study according to OECD guideline 404 in 6 New Zealand White rabbits. The animals were exposed to the test substance for 24 hours. No effects on the skin (erythema and edema) were observed in all animals at any observation time after application.

There is one reliable study available on the eye irritancy potential. Hostavin 3206 was tested for its eye irritant properties in 3 New Zealand White. This study was performed according to OECD Guideline 405. No effects were observed in all animals 24, 48 and 72 hours after application.

Justification for selection of skin irritation / corrosion endpoint:
Well performed and reported study equivalent to OECD guideline 404.

Justification for selection of eye irritation endpoint:
Well performed and reported study equivalent to OECD guideline 405.

Justification for classification or non-classification

With reference the reported scores 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).

With reference the absence of effects Hostavin 3206 does not have to be classified as irritant to the eyes 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).