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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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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 with acceptable restrictions

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

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt
EC Number:
228-058-4
EC Name:
Hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt
Cas Number:
6104-58-1
Molecular formula:
C47H49N3O7S2.Na
IUPAC Name:
hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Appearance: Blue colouring
Physical state: 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 kg (males) and 2.66 kg (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:
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 (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.

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: 4

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 24 hours
Score:
0.83
Max. score:
2
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 24 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 24 hours
Score:
2.17
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 24 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Abraded 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.

Any other information on results incl. tables

Scoring tables

Table: Erythema scores- intact skin

Erythema
Animal Observation time
24 hours 72 hours
11 1 0
12 1 0
13 0 0
14 0 0
15 1 0
16 2 0
  0.83 0

Table: Erythema scores: abraded skin

Animal Observation time
24 hours 72 hours
11 1 0
12 0 0
13 0 0
14 0 0
15 1 0
16 2 0
  0.67 0

Table: Oedema scores - intact skin

Animal Observation time
24 hours 72 hours
11 2 0
12 2 0
13 2 0
14 2 0
15 3 0
16 2 0
  2.17 0

Table: Oedema scores: abraded skin

Animal Observation time
24 hours 72 hours
11 2 0
12 2 0
13 2 0
14 2 0
15 2 0
16 2 0
  2.00 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20085/A is not a skin irritant in the albino rabbit.
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). 3 males and 3 females were used in the test.

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 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.

EXPERIMENTAL RESULTS:

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. However, the scores fail to meet the threshold criteria of classification as set forth by the Regulation (EC) No. 1272/2008. In conclusion, FAT 20085/A is considered to be not a skin irritant in the albino rabbit.