Reaction mass of (disodium 4-[[4-(acetylmethylamino)-2-sulphonatophenyl]amino]1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and sodium sulphate and sodium chloride)

Skin irritation / corrosion

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:

other: early study pre-dating GLP-regulations but giving the relevant details of the study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

abraded and intact skin

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41

GLP compliance:

no

Remarks:

pre-dates GLP-regulation

Test material

Test material information

Constituent 1

Reference substance name:

pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate

EC Number:

944-710-7

Molecular formula:

not available because multi-constituent substance

IUPAC Name:

pentasodium 1-amino-4-{[4-(N-methylacetamido)-2-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate chloride sulfate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: all

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None of the animals showed any observable response to treatment throughout the 72 hours observation period

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is considered to be non-irritant to rabbit skin.

Executive summary:

Primary irritation to the skin was measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects were used per skin tests.

Under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5 gram of the test substance were introduced. The test item was moistened with water.

The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animals was then wrapped with an impervious material such as rubberized.cloth for the 24 -hour period of exposure.

After 24 hours exposure, the patches were removed and the resulting reactions were evaluated

None of the animals showed any observable response to treatment throughout the 72 hours observation period