Hydrogen [4-[[4-(diethylamino)-o-tolyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Blue 015 - Similar Substance 01

IUPAC Name:

Acid Blue 015 - Similar Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals:
Healthy New Zealand White rabbits (Porton strain) aged 3-4 months with average body weights of 2.71 Kgs. (Males) and 2.66 Kgs. (Females), bred on the premises and maintained under a semi-barrier system. Six rabbits ( 3 males and 3 females) were acclimatized in the test
area for one week prior to the start of the trial.

Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (± 1 °C) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 10 hours daily from 08.00 -18..00 hours.
A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved or abraded

Vehicle:

water

Controls:

no

Amount / concentration applied:

10g of the test compound was mixed with 10ml. of water to make a solution of 15ml. 0.75ml of which was applied to each test site (0.5 g).

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

Six rabbits (3 males and 3 females).

Details on study design:

Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.

10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml 0.75 ml- of which was applied to each test site on a 2.5 cm square gauze pad.
These were covered with aluminium foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Coban"** self-adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema.
A further assessment was made at 72 hours.

*Smith and Nephew, Hull, England.
**3M Comapny, Wigmore Street, London.

SCORING SYSTEM:

Erythema and Eschar Formation:
*No erythema: 0
*Slight erythema (barely perceptible): 1
*Well defined erythema: 2
*Moderate to severe erythema: 3
*Severe erythema (beet red) to slight eschar formation:

Oedema formation:
*No oedema: 0
*Very slight oedema (barely perceptible): 1
*Slight oedema (edges of area well defined by definite raising): 2
*Moderate oedema (raised approximately 1 mm): 3
*Severe-oedema (raised more than 1 mm and extending beyond the area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 11, 13, 14

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

erythema score

Basis:

animal: 12, 15

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

animal: 16

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

animal: 11, 12, 13, 15, 16

Time point:

24/48/72 h

Score:

ca. 1.66

Max. score:

2

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: Intact skin

Results 5

Irritation parameter:

edema score

Basis:

animal: 14

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 3 days

Remarks on result:

other: Intact skin

Irritant / corrosive response data:

Slight to well defined erythema, and slight to moderate oedema were seen in 4/6 and 6/6 rabbits respectively 24 hours after application of the
compound. All sites were normal by 72 hours.
The primary irritation score was 1.4
-

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

The primary skin irritation test in Albino rabbits with compound FAT 20085/A was conducted according to the method "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

To performed this experiment 3 healthy rabbits males and 3 females were used.

Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of

the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were

sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand sit'a remained intact.

10 g of the tost compound was mixed with 10 ml of water to make a solution of 15 ml 0.75 ml.- of which was applied to each test site

on a 2.5 cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self-adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema.

A further assessment was made at 72 hours.

Slight to well defined erythema, and slight to moderate oedema were seen in 4/6 end 6/6 rabbits respectively 24 hours after application of the compound. All sites were normal by 72 hours.

The primary irritation score was 1.4.

In conclusion, the test substance is not irritant in rabbit skin according to the CLP No 1272/2008.