Benzamide, N-[[4-[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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:

02 Nov - 05 Nov 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 24 Apr 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 28 Jul 2015

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: Crl:KBL(NZW)BR

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany
- Age at study initiation: Young adults (actual ages not stated)
- Weight at study initiation: 2.9 kg - 3.8 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding.
- Diet: Standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaten GmbH, Soest, Germany), approx. 100 g/animal/day, ad libitum.
- Water: Tap water from polycarbonate bottles, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 2004-11-02 To 2004-11-05

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

The pulverized test substance was moistened with Aqua p.i. to ensure good contact with the skin.

Controls:

other: untreated dorsolateral skin site of same animal served as control

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

Initial test (1 animal): 3 min, 1 and 4 h.
Confrimatory test (2 animals): 4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h after patch removal.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 on the dorsal area of the trunk.
- Type of wrap if used: Gauze patch held in place with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, skin was carefully washed with water.
- Time after start of exposure: Initial test 3 min, 1 and 4 h. Confrimatory test 4 h.

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 h after patch removal.

SCORING SYSTEM:
- Method of calculation: Draize scoring system.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No evidence of skin irritation was observed

Other effects:

No treatment-related signs of toxicity.

Interpretation of results:

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

Conclusions:

The study was performed in accordance to OECD TG 404 under GLP conditions and is considered reliable. The test substance was determined to be non-irritating.

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:

21 Jun - 24 Jun 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 Apr 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 9 Oct 2017

Deviations:

yes

Remarks:

No use of analgesics.

GLP compliance:

yes

Species:

rabbit

Strain:

other: Crl:KBL(NZW)BR

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany.
- Age at study initiation: Young adults (actual ages not stated)
- Body weight at study initiation: 2.9 - 3.8 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding, changed at least twice weekly and animals were regularly transferred to clean cages.
- Diet: Approx. 100 g/animal/day standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaten GmbH, 59494 Soest, Germany) .
- Water: Tap water from polycarbonate bottles, ad libitum.
- Acclimatization period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Room temperature: 20 ±3 °C
- Air humidity: 50 ± 25 %
- Air changes (per hr): approx. 10
- Light/ Dark cycle (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2005-06-21 To 2005-06-24

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eyes served as control

Amount / concentration applied:

- Amount (s) applied: 0.1 g (pulverized test substance).

Duration of treatment / exposure:

Single application without washing.

Observation period (in vivo):

72 h
Reading time points: 1,24,48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eye was not rinsed for at least 24 hours following instillation.

SCORING SYSTEM: Draize scoring system.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Conjunctival redness, grade 2 was the only finding 1 h after treatment in all 3 animals. However, reversibility was evident and conjunctival redness grade 1 was observed in all 3 animals at 24 h post-treatment and in one animal only at 48 h. Ocular effects were completely resolved in all animals at 72 h.

Other effects:

There was reduced food intake in 2/3 test animals which was considered to be not test substance related by the investigators.

Interpretation of results:

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

Conclusions:

The study was performed in accordance to OECD TG 405 under GLP conditions and is considered reliable. The test substance was determined to be non-irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin irritation/corrosion study was performed in accordance with OECD 404 (M-129076-01-1, 2004). The test substance was moistened with water and placed on a gauze patch. The gauze patch was applied to the intact skin of Crl:KBL(NZW)BR albino rabbits under semi-occlusive conditions for exposure periods of 3 min, 1 h or 4 h. After the respective treatment, the gauze patch was removed and the treated skin site was cleaned. Observation of the treated skin sites following 3 min or 1 h exposure was done immediately after patch removal. For the 4 h exposure, the evaluation of irritant effects was performed at 1, 24, 48 and 72 h after patch removal. There were no signs of skin irritation or corrosion at the treated skin sites. All scores at any observation time points were 0. Under the test conditions, the test substance was not irritating to the skin.

 

The eye irritation study was performed in accordance with OECD 405 (M-258984-01-1, 2005). The unchanged test substance was applied in the conjunctival sac of one eye of each Crl:KBL(NZW)BR albino rabbit, the untreated eye served as the control. 1, 24, 48 and 72 h after test substance instillation, the grades of ocular reaction (conjunctivae, cornea, iris) were recorded. Conjunctival redness (score 1-2) was observed in all three animals, but was fully reversible within 48 h post application in two animals. The third animal recovered within 72 h post application. No other eye irritation effects were noted. Under the test conditions, the test substance was not irritating to the eyes.

Justification for classification or non-classification

The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.