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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:
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)
Deviations:
yes
Remarks:
Testing was conducted on abraded and intact skin areas. Abration represents an elevated testing condition when compared to OECD guideline 404, therefore, data obtained uder abrasive conditions should not be taken into account for hazard assessment.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Sodium 2-(2 or 3-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate and Sodium 2-(3 or 2-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate
EC Number:
942-981-6
Molecular formula:
C36H33ClN3NaO7S
IUPAC Name:
Reaction mass of Sodium 2-(2 or 3-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate and Sodium 2-(3 or 2-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bred on the premises of the testing laboratory
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: Males: 2.27 kg; Females: 2.07 kg
- Housing: Caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: Sterile filtered water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1°C
- Humidity: 50-70 %
- Photoperiod: Animals were exposed to artificial light for 10 h daily from 08.00 - 18.00 h

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both abraded and intact skin areas lateral to the midline of the back
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
10 g 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 on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
24 h
Observation period:
Up to 72 h (the skin reactions were assessed at 24 and 72 h)
Number of animals:
six animals (five males and one female)
Details on study design:
TEST SITE
- 24 h prior to the dermal application, the backs of the animals 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 animal. 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.
- The test substance was applied to each test site on a 2.5 cm² gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6 inch 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.

SCORING SYSTEM: Draize scoring system

Erythema and Eschar Formation
Description
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
Description
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area tuell 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
Remarks:
intact skin
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #6
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritant / corrosive response data:
A slight erythema and a very slight to moderate oedema was seen in 4/6 and 6/6 rabbits respectively, 24 hours after application of the compound. Very slight oedema was still present at 2/6 abraded sites at 72 hours. The reactions at intact sites were slightly less severe than at abraded sites. The primary irritation score was 1.1.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20077/A was considered to be not an irritant to skin
Executive summary:

The skin irritation potential of FAT 20077/A was evaluated in a study conducted according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Six New Zealand White rabbits were exposed to the test substance on intact as well as abraded skin for 24 hours. Observations of erythema and edema were made at 24 and 72 hours. A slight erythema and a very slight to moderate oedema was seen in 4/6 and 6/6 rabbits respectively, 24 hours after application of the compound. Very slight oedema was still present at 2/6 abraded sites at 72 hours. The reactions at intact sites were slightly less severe than at abraded sites. The scores recorded are below the threshold scores required for classification for skin irritation as given in Regulation (EC) no. 1272/2008. Hence, FAT 20077/A was considered to be not an irritant to skin as per the provisions of Regulation (EC) No. 1272/2008.