N-{[Benzyl(ethyl)amino]-[(chloro-cyano-nitrophenyl)substituted]phenyl}acetamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: In Vivo Bio Sciences. Shed No.23, Assessment No.154, Kodigehalli Village,Magadi Road, Bangalore - 560091 Karnataka, India.

Age at treatment : 3 months

Body weight range at treatment : 2.2895 to 2.3708 kgs

Acclimatization : One rabbit (RBa4287) was acclimatized for six days while the other two (RBa4288 and RBa4289) rabbits were acclimatized for seven days under laboratory conditions after physical examination.

Housing : The rabbits were housed individually in rabbit cages (LxBxH 65 x 65 x 45 cm) with noryl shallow cage body and facilities for pelletted food (Stainless steel feed hopper) and drinking water (750 mL markrolon bottle fitted with sipper tube). The litter collection trays (noryl waste tray) were changed daily (except on Sundays). The water bottle and feed hopper were changed once a week. The noryl shallow cage body and the rack were washed once in 15 days.

Diet: ad libitum
The animals were offered rabbit feed manufactured Krishna Valley Agro Tech LLP, MIDC Kupwad block, Sangli, Maharashtra.

Water: ad libitum
The animals were provided deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India.

Environmental Conditions :
Animals were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (13.2 air changes/hour). Temperature : 21 to 23°C, relative humidity : 65 to 67% with a 12 hour light and 12 hour dark cycle.
The maximum and minimum temperature and relative humidity in the experimental room were recorded once daily. The relative humidity in the experimental room was calculated from dry and wet bulb temperature recordings.

IN-LIFE DATES : 24 July 2018 to 30 July 2018.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg of test item was added to 1 mL of Milli-Q water to form paste.

Negative control : Milli-Q water

VEHICLE
- The test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal's skin.

Duration of treatment / exposure:

4 h

Observation period:

Up to 72 h (The skin reactions were assessed at approximately 45 min, 24, 48 and 72 h after the removal of the dressings and test substance)

Number of animals:

Three male animals.

Details on study design:

TEST SITE
- Area of exposure: Approx. 6 cm²
- Type of wrap if used:The patches were held in place by a strip of adhesive tape and crepe elastic bandage wound around the torso, which was anchored using safety pins.

REMOVAL OF TEST SUBSTANCE
- Washing : Removed at the end of the exposure period using a tissue moistened with tap water and subsequently.
- 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:

0

Max. score:

4

Remarks on result:

other:

Remarks:

black colour imparted by the test item on the treated area on 24hr observation period only.

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other:

Remarks:

black colour imparted by the test item on the treated area on 24hr observation period only.

Results 3

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 4

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 5

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 6

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:

No corrosion or skin irritation was observed during the study.

Other effects:

Colouration: Black staining of the treated skin by the test substance was observed for animal #1 for time point of 24h.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was considered to be a non-irritant to skin.

Executive summary:

A study was performed to assess the skin irritation potential of the FAT 41047/A (of ca. 93.09 % purity) in New Zealand White rabbits according to OECD Guideline 404 in compliance with GLP.

500 mg of test substance was dissolved in 1mL of Milli-Q water to form a paste which was applied to clipped skin area of each animal under a 2 x 3 sq.cm gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 60 minutes, 24h, 48h and 72 h respectively. All test animals were monitored daily for viability, mortality and clinical signs. Body weights were recorded pre-test and at study termination.

Black staining of the treated skin by the test substance was observed, which made scoring of erythema difficult at 60 minutes and 24 h in 1/3 animals. No erythema or oedema was observed for skin irritation at 1/24/48/72 hrs. The erythema and edema score was zero at all time points. No signs of body weight variability, toxicity or mortality were observed in any animal during the study period.

Based on the findings of this study, the test substance was considered to be non-irritating to skin.