2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide

Endpoint summary

Description of key information

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Neither erythema nor edema were noted 24 and 48 h after end of exposure. The test material is not irritating to skin under these test conditions.

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals each. The eyes were washed 24 h after application and eye responses were noted for 72 h. Slight effects on the conjunctiva 1 and 7 hours after start of the exposure were no longer visible at later time points.No effects were observed 24, 48 and 72 hours after start of the exposure.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23 NOV 1976 to 26 NOV 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)

Deviations:

not specified

GLP compliance:

no

Remarks:

study was performed previous to GLP implementation

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1,5-2,0 kg
- Housing: single
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm, Germany), ad libitum
- Water: tap water, ad libitum

Type of coverage:

occlusive

Preparation of test site:

other: clipped/intact or clipped/scarified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg

Duration of treatment / exposure:

24 h

Observation period:

48 h after end of exposure

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p. 27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 48 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Remarks on result:

other: intact and scarified

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 48 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Remarks on result:

other: intact and scarified

Irritant / corrosive response data:

Erythema and edema scores immediately after exposure were 0 as well as at later time points.
The same results were observed with scarified skin

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is not irritating to skin under these test conditions. This conclusion is legitimate even though the applied testing regime differs from today's standard methods, as no skin responses were observed in 6/6 animals 24 and 48 h after exposure, which lasted 20 h longer than required by OECD TG 404.

Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Neither erythema nor edema were noted 24 and 48 h after end of exposure. The test material is not irritating to skin under these test conditions.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23 NOV 1976 to 26 NOV 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)

Deviations:

not specified

GLP compliance:

no

Remarks:

study was performed previous to GLP implementation

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: single
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm, Germany), ad libitum
- Water: tap water, ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not relevant since no effect

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: not relevant since no effect

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant since no effect

Irritant / corrosive response data:

Redness of the conjunctiva was observed in all six animals at the 1 h reading (scores 1) . This effect was still obervable at the 7 h reading, but was completely reversible 24 h after application (score 0). Chemosis was noted in three animals at the 1 h reading (individual scores are 1). This effect was reversible at the 7 h reading. No other effects on the eyes were observed.

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.

Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals each. The eyes were washed 24 h after application and eye responses were noted for 72 h. Slight effects on the conjunctiva 1 and 7 hours after start of the exposure were no longer visible at later time points. No effects were observed 24, 48 and 72 hours after start of the exposure.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No classification

The test item did not cause irritant effects after dermal or ocular exposure in vivo.