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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:
1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
EC Number:
300-644-5
EC Name:
Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
Cas Number:
93951-21-4
Molecular formula:
C27H27N5O20S6.4Na C27H27N5Na4O20S6
IUPAC Name:
tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Navy 81-1030

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The New Zealand White rabbit , weighing 2.0 - 3 .0 kg and approximately 9-10 weeks of age, was used for this study.

The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
The rabbits were not used in any previous study and were accl imated to the laboratory for at least 5 days prior to dosing.

The animals were randomized using a computer generated list of random numbers. They were individually identified by ear tag.
Each cage was identified with a cage card displaying the animal number, sex, project number, test article , date dosed , dose level, and responsible technician's initials.

Husbandry Conditions:
Temperature - 70°F ~ 2°F
Relative Humidity - 45% ~ 5%
Light - 12 hour light/dark cycle
Diet - Wayne 15% Rabbit
Ration and tap water were provided ad libitum. Based on our current knowledge no contaminants were known to be in this diet or water that might be expected to interfere with the objectives of the study.

Caging - Stainless steel with elevated wire mesh flooring
1 rabbit/cage

Bedding - Techboard
Shepherd Products Company
Kalamazoo, Michigan 49005

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 h
Observation period:
examination after removal and 2 days later
Number of animals:
6
Details on study design:
A group of six rabbits was clipped over a wide area on their backs approximately 24 hours prior to application.
One side of the animals' backs was abraded at two sites with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. Two intact skin sites were also selected on the other side of the back.

A 0.5 g portion of the experimental material was applied to two abraded and two intact skin sites on the same rabbit.
Gauze patches were then placed over the treated areas and an impervious material wrapped snugly around the trunks of the animals to hold the patches in place. The wrapping was removed at the end of the twenty-four hour contact period, the sites wiped but not washed, and the treated areas examined.

Readings were also made after seventytwo hours. The Draize method of scoring was employed. All other lesions observed were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of systemic toxicity were observed during the 72 hours of observation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The material does not appear to be a skin irritant .
Executive summary:

A group of six rabbits was clipped over a wide area on their backs approximately 24 hours prior to application. One side of the animals' backs was abraded at two sites with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. Two intact skin sites were also selected on the other side of the back.

A 0.5 g portion of the experimental material was applied to two abraded and two intact skin sites on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material wrapped snugly around the trunks of the animals to hold the patches in place. The wrapping was removed at the end of the twenty-four hour contact period, the sites wiped but not washed, and the

treated areas examined. Readings were also made after seventytwo hours. The Draize method of scoring was employed. All

other lesions observed were recorded.

Primary Irritation Score: 0

The material does not appear to be a skin irritant .