2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology was equivalent or similar to OECD 404 and in accordance with the Principles of Good Laboratory Practice (GLP)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not Applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

EC Number:

296-120-8

EC Name:

2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.

Cas Number:

92257-31-3

Molecular formula:

Not applicable

IUPAC Name:

2-​Naphthalenol, 1-​[2-​[4-​(2-​phenyldiazenyl)​phenyl]​diazenyl]​-​, ar-​heptyl ar',​ar''-​Me derivatives *

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
-Source: New York State Rabbit Development, Hartwick, N.Y.
-Weight at Initiation: Approximately 2-4kg
-Identification: Ear tag, Cage tab
-Housing: Individually housed in wire mesh bottom cages
-Diet: HIH Animal Feed A, certified feed, ad libitum. Supplied fresh daily.
-Water: Tap wate, ad libitum.
-Quarantine: Minimum of 5 days

ENVIRONMENTAL CONDITIONS
-Temperature: as per "Guide for the care and use of Laboratory Animals"
-Humidity: as per "Guide for the care and use of Laboratory Animals"
-Air Changes (per hour): 12-15 air changes/hour
-Photoperiod (hrs dark/hrs light): 12 hours light/dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of Automate Red B nonvolatile

Duration of treatment / exposure:

Four hours post-dose, the occlusive binders and patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible.

Observation period:

One-half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the method of Draize. The exposure sites were again examined and scored at 48, 72 and 96 hours.

Number of animals:

6 rabbits

Details on study design:

Animals will be weighted and the weights recorded prior to the initiation of the study. Approximately 24 hours prior to dosing, the fur shall be clipped from the back and flanks of each animal. Just prior to application of the test article the right dorsal side of each animal will be abraded with the point of a 22 guage clean hypodermic needle. The abrasions will penetrate the stratum corneum but will not be deep enough to disturb the dermis or cause bleeding. The test article will be applied to each of the to sites per animal, one on abraded skin and the other on intact skin. All sites will have an area of one square inch. If necessary, a glass rod will be used to evenly distribute the test article. Each test site shall be occluded with a one square inch gauze patch, two single layers thick, held on with masking tape and the area subsequently secured by a nonabsorbant binder according to FDRL's Standard Operating Procedures. The binders will be left on the animals for 4 hours follwoing application of the test article. At that time, the binders will be removed and the test areas gently wiped using a soft clean gauze. Skin sites will be examined at 30-60 minutes, and then at 24, 48, and 72 hours after patch removal. Erythema and edema will be scored individually and evaluated according to the method of Draize, 1965.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

6 rabbits

Basis:

mean

Remarks:

0.0

Time point:

other: 24.5, 48, 72, and 96 hours

Score:

0

Max. score:

4

Remarks on result:

other: Results for intact skin

Results 2

Irritation parameter:

edema score

Remarks:

6 rabbits

Basis:

mean

Remarks:

0.0

Time point:

other: 24.5, 48, 72, and 96 hours

Score:

0

Max. score:

4

Remarks on result:

other: Results for intact skin

Results 3

Irritation parameter:

erythema score

Remarks:

6 rabbits

Basis:

mean

Remarks:

0.0

Time point:

other: 24.5, 48, 72 and 96 hours

Score:

0

Max. score:

4

Remarks on result:

other: Results for abraded skin

Results 4

Irritation parameter:

edema score

Remarks:

6 rabbits

Basis:

mean

Remarks:

0.0

Time point:

other: 24.5, 48, 72 and 96 hours

Score:

0

Max. score:

4

Remarks on result:

other: Results for abraded skin

Irritant / corrosive response data:

non-irritating

Other effects:

None

Any other information on results incl. tables

Based on the individual animal mean score for the 24.5, 48 and 72 hr time-point for each parameter (Erythema and Eschar Formation and Edema Formation) on intact skin, this material would not be classified under EU regulations.

			Rabbit Number
Parameter scored	Exposure Time (hours)	Skin	1116	1117	1118	1119	1121	1122
Erythema and Eschar Formation	24.5	Intact	0	0	0	0	0	0
	48	Intact	0	0	0	0	0	0
	72	Intact	0	0	0	0	0	0
Mean score for 24.5, 48 and 72 h time-point			0	0	0	0	0	0
(A)Erythema and Eschar Sub-total					0	0	0	0
Edema Formation	24.5	Intact	0	0	0	0	0	0
	48	Intact	0	0	0	0	0	0
	72	Intact	0	0	0	0	0	0
Mean score for 24.5, 48 and 72 h time-point			0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material is non-irritating.

Executive summary:

The skin irritation potential of the test material was evaluated in 6 New Zealand rabbits. A single dermal application of 0.5 ml of undiluted test material was applied to the abraded and intact skin of the rabbits under an occlusive wrap. Four hours post-dose, the occlusive binders and patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible. One-half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the method of Draize. The exposure sites were again examined and scored at 48, 72 and 96 hours. Based on the results of the study, the test material is considered to be non-irritating.