Methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ETAD test method 14.10.76

Version / remarks:

Hazleton Manual of Standard Operating Procedures as applied to ETAD test method 14.10.76 from Code of Federal Regulations, Title 16, Section 1400.41

Deviations:

no

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

EC Number:

261-874-9

EC Name:

Methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

Cas Number:

59709-38-5

Molecular formula:

C20H20BrClN4O6

IUPAC Name:

methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

Test material form:

solid: granular

Details on test material:

Disperse Brown 19

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six New Zealand White rabbits, free from any obvious skin lesions and weighing not less than 2.0 kg were used for the study. They were obtained from Buxted Rabbit Co. Ltd., Great Totease Farm, Buxted, Nr. Uckfield, Sussex.

Diet
The animals were allowed unlimited access to mains water and food (Standard Rabbit Diet - BP Nutrition (U.K.) Ltd., Stepfield, Witham, Essex) throughout the study.

Environment
The animals were housed individually in grid floor cages in a single room maintained under conditions of ambient humidity and temperature except that a lower temperature of 14°C is automatically imposed, and exposed to natural lighting conditions.

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 animals

Details on study design:

Procedure and observations
The animals were identified by a number stamped on a metal ear tag.
Twenty four hours prior to treatment, the back of each animal was shaved using electric clippers. One side of the shaven area on each animal was left intact. The other side of the shaven area was abraded using a sterile hypodermic needle to scratch a 5 x 5 lattice in an area measuring 2.5 cm x 2.5 cm such that only the stratum corneum was penetrated and bleeding did not occur. The test article (0.5 .g) was applied under gauze pads (2.5 cm x 2.5 cm) to the intact and abraded areas of each rabbit.
The patches were secured by adhesive strapping and the whole trunk further occluded with a stockinette bandage.
Twenty four hours after administration the patches were removed and the skin reactions on both the intact and abraded areas of each rabbit were scored according to Draize, J.H. (1959), Assoc. of Food and Drug Officials of the U.S., Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.". The evaluation was repeated 48 hours later (72 hours after administration) and finally 7 days after administration if any irritation was apparent at the 72 hour reading.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The primary irritation index of test article Y0154/001 was 0.0. The test article was therefore classified as a non irritant.

Other effects:

Red/brown staining of the test area and surrounding skin made the irritation assessment difficult.

Any other information on results incl. tables

Skin irritation reactions

Test article/concentration: Y0154/001, as supplied
Rabbit number	Time (hours)	Erythema		Oedema
		A	I	A	I
688	24	0	0	0	0
	72	0	0	0	0
689	24	0	0	0	0
	72	0	0	0	0
691	24	0	0	0	0
	72	0	0	0	0
692	24	0	0	0	0
	72	0	0	0	0
693	24	0	0	0	0
	72	0	0	0	0
694	24	0	0	0	0
	72	0	0	0	0
	Sub total	0	0	0	0
	Total	0		0
Sex    Male	Primary irritation index	0/24 = 0.0

A = abraded skinI = intact skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance did not show any signs of irritation (erythema and edema score: 0.0). The substance is not classifiable according to CLP criteria.

Executive summary:

The study was carried out to determine the primary irritation index of test article in the albino rabbit. The study was performed in accordance with the Standard Operating Procedures as applied to the ETAD test method 14.10.76 from Code of Federal Regulations, Title 16, Section 140041.

 

Six New Zealand White rabbits, free from any obvious skin lesions and weighing not less than 2.0 kg were used for the study.

Twenty four hours prior to treatment, the back of each animal was shaved using electric clippers. One side of the shaven area on each animal was left intact. The other side of the shaven area was abraded using a sterile hypodermic needle. The test article (0.5 .g) was applied under gauze pads to the intact and abraded areas of each rabbit. The patches were secured by adhesive strapping and the whole trunk further occluded with a stockinette bandage.

Twenty four hours after administration the patches were removed and the skin reactions on both the intact and abraded areas of each rabbit were scored. The evaluation was repeated 48 hours later (72 hours after administration) and finally 7 days after administration if any irritation was apparent at the 72 hour reading.

 

Results

The primary irritation index of test article was 0.0. The test article was therefore classified as a non irritant.

Red/brown staining of the test area and surrounding skin made the irritation assessment difficult.

 

Conclusion

A primary skin irritation study was performed in the albino rabbit on the test article.

A primary irritation index of 0.0 was obtained. The test article is therefore classified as a non-irritant.