Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5-19-1993 to 5-22-1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: EPA/OECD guideline study performed in accordance with GLP; exact details of test material (certificate of analysis, Characterisation) are not included in the report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol

EC Number:

915-586-1

Molecular formula:

Variable; substance is a UVCB.

IUPAC Name:

Reaction mass of 2,4-bis(xylylazo)resorcinol and 2,4-bis[(4-dodecylphenyl)azo]resorcinol and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol

Test material form:

other: Semi-solid

Details on test material:

The test material was a red colored semi-solid, identified as Automate Yellow 8 Petroleum. The test material was administered undiluted. Records of the test article stability, purity, source, and other data required by Federal Regulations will be maintained by the Sponsor.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six young adult, male New Zealand Albino rabbits were used for this study. The rabbits were obtained from Oak Hill, Holland, Michigan, and weighed between 2.30 and 2.71 kg at study initiation. The rabbits were identified by ear tags and were individually housed in stainless steel cages in a temperature, humidity and light-controlled room in our AAALAC accredited facility (rm. 14). The animals were maintained according to the recommendations contained in the DHHS Publication No. 86-23 (NIH): Revised 1985, "Guide for the Care and Use of Laboratory Animals." They were conditioned for five days prior to the initiation of the study. Purina Rabbit Chow (ca. 350 gm) was placed in the feeders each morning during the study. Tap water from an automatic watering system was available ad libitum from arrival until termination. Six animals were selected randomly from the acclimated colony and assigned to the test group. The animals used for this study were considered to be in good health at study initiation.

Justification for Selection of Test System: The New Zealand Albino rabbit has been used extensively as an animal model for skin irritation testing.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g of undiluted test material.

Duration of treatment / exposure:

4 hours.

Observation period:

Rabbits were weighed at the initiation and termination of the study. Dermal irritation readings were performed approximately 30 minutes after patches were removed (4.5 hours), as well as 24, 48 and 72 hours after treatment.

Number of animals:

6 animals.

Details on study design:

Twenty four hours prior to study initiation, electric clippers were used to remove the hair from an 8 x 8 cm area located on the left flank of each animal. 0.5 grams of the test material was flattened into a wafer and applied to the intact site of each rabbit. The test material was then covered with a 4 x 4 gauze pad and the entire trunk wrapped with 4 mil plastic wrap. The ends of the plastic wrap were then sealed with surgical tape. The covering material was removed after a four hour contact period, and excess test material was wiped from the site. The study was terminated at the end of 4 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: Mean score for all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: unabraded sites

Results 2

Irritation parameter:

edema score

Basis:

animal: Mean score for all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: unabraded sites

Any other information on results incl. tables

Grading and scoring of irritation were performed in accordance with the Draize scoring system (Appendix 1). Individual and group mean body weights as well as individual and mean primary skin irritation scores for the test material are presented in Appendix 2. There was no irritation observed in any of the six animals thoughout the study. The Primary Irritation Index, based upon 4.5, 24, 48 and 72 hour scores, was 0/8.00.

APPENDIX 2: INDIVIDUAL AND MEAN PRIMARY SKIN IRRITATION SCORES (Unabraded sites)

Animal #	Initial Weight (kg)	Final Weight (Kg)	4.5 Hours		24 Hours		48 Hours		72 Hours
			Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
435	2.30	2.35	0	0	0	0	0	0	0	0
441	2.33	2.40	0	0	0	0	0	0	0	0
448	2.54	2.59	0	0	0	0	0	0	0	0
449	2.31	2.44	0	0	0	0	0	0	0	0
452	2.55	2.57	0	0	0	0	0	0	0	0
454	2.71	2.78	0	0	0	0	0	0	0	0
Mean +SD	2.46 0.17	2.52 0.16	0	0	0	0	0	0	0	0
Daily Mean Primary Irritation Score (=er+ed)			0		0		0		0
Primary Irritation Index (4.5, 24, 48 and 72 hrs/4)			0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the results of this study the test material, Automate Yellow 8 Petroleum, produced a Primary Irritation Index of 0/8.00 and would be considered non-irritating to the skin of the rabbit. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.

Executive summary:

Automate Yellow 8 Petroleum (0.5 g) was applied to an unabraded site on the shaved left flank of each of six male albino rabbits for a four hour contact period. The application sites were graded for skin irritation at 4.5, 24, 48 and 72 hours after compound administration. There was no irritation observed in any of the six animals thoughout the study. The Primary Irritation Index, based upon 4.5,24,48 and 72 hour scores, was 0/8.00. Based upon the results of this study the test material, Automate Yellow 8 Petroleum, produced a Primary Irritation Index of 0/8.00 and would be considered non-irritating to the skin of rabbits. Based on the mean scores for the 24, 48 and 72 hr time-points for each animal, this material would not be classified under the GHS system of classification.