(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 May 1979 to 22 June 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed in accordance with Section 162.81 of the Regulations for the Enforcement of the Federal .Insecticide, Fungicide, and Rodenticide Act, (Federal Register , Wednesday, June 25, 1975). GLP status not reported.

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: Section 162.81 of the Regulations for the Enforcement of the Federal .Insecticide, Fungicide, and Rodenticide Act, (Federal Register, Wednesday, June 25, 1975).

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

EC Number:

274-572-7

EC Name:

(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Cas Number:

70331-94-1

Molecular formula:

C40H60N2O8

IUPAC Name:

(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

TVCI B-5909 .is a white powder.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

New Zealand White rabbits from Willoughby's Rabbitry.
The rabbits were acclimated to the laboratory for a t least one day before they were dosed. The rabbits were individually identified by means of numbered ear tags.

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

0.5 grammes of the undiluted test material was applied, moistened with physiological saline

Duration of treatment / exposure:

24 hour

Observation period:

72 hours

Number of animals:

Six animals

Details on study design:

0.5 grames of the undiluted test material was moistened with physiological saline and applied under a one-inch square surgical gauze patch, two layers thick, to two intact skin areas and two abraded skin areas of each of six New Zealand White rabbits. The application sites were prepared by clipping the hair from the saddle area of the rabbits. The abraded areas were prepared by making minor epidermal incisions with a hypodermic needle. The abrasions were sufficiently deep penetrate the epidermis, but not to induce bleeding. Each patch was held in place with two strips on one-inch adhesive tape. After application of the patches, the truck of each rabbit was wrapped with rubber dental daming, which was secured with staples. An outer layer of gauze and tape was placed around the truck of each animal. The animals were restrained in Newmann harnesses for 24 hours.
At the end of the 24-hour exposure period, the patches were removed and any residual sample was gently wiped from the skin with a soft dry towel.
The reactions were scored immediately after removal of the patches 24-hour reading and again two day later 72-hour reading, according to the Draize scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No irritative effects were noted at any site throughout the study.

Other effects:

None specified

Any other information on results incl. tables

Primary irritation scores in New Zealand White rabbits following a 24-hour patch application of TVCI B-5909

Skin	Time Hours	Score for Rabbit Number												Total Score	Average
		1		2		3		4		5		6
		(141)		(142)		(143)		(144)		(145)		(146)
Erythema and Eschar Formation
	Site	A	C	B	D	C	A	D	B	A	C	B	D
Intact	24 72	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
	Site	B	D	C	A	D	B	A	C	B	D	C	A
Abraded	24 72	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Edema Formation
	Site	A	C	B	D	C	A	D	B	A	C	B	D
Intact	24 72	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
	Site	B	D	C	A	D	B	A	C	B	D	C	A
Abraded	24 72	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Primary Irritation Index 0

 

Site Key – Dorsal View of Rabbit

Head
A	C
B	D
Tail

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

TVCI B-5909 produced no irritating effects following application to the intact and abraded skin of New Zealand White rabbits.

Executive summary:

The purpose of this study was to evaluate the acute dermal irritation potential of the test material in accordance with Section 162.81 of the Regulations for the Enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act, (Federal Register, Wednesday, June 25, 1975).

 

0.5g of the undiluted test material was moistened with and applied to two intact skin areas and two abraded skin areas on each of six New Zealand White rabbits.

At the end of the 24-hour exposure period, the patches were removed and any residual sample was gently wiped from the skin with a soft dry towel.

The reactions were scored immediately after removal of the patches 24-hour reading, and again two days later 72-hour reading.

 

TVCI B-5909 produced no irritating effects following application to the intact and abraded skin of New Zealand White rabbits.

 

The primary irritation index was found to be 0.

 

Based on these results TVCI B-5909 is classified in Toxicity IV for skin effects as these categories are described in Section 162.10 of the above-ci ted Regulations (Federal Register, Thursday, July 3, 1975). This corresponds to "not irritating" under The CLP Regulation. European Regulation (EC) No 1272/2008.