Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

EC Number:

274-366-7

EC Name:

Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

Cas Number:

70179-77-0

Molecular formula:

C28H30N2O8S.Na

IUPAC Name:

sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate

Test material form:

solid: particulate/powder

Details on test material:

Sponsor's identification NYVIT
Batch number Op 1S 1005
Date received 21 May 1991
Description dark maroon powder
Container opaque plastic bottle
Storage conditions room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were individually housed in suspended metal cages.
Free access to mains drinking water and food (Spillers Rabbit Diet,
Dalgety Agriculture Ltd., Almondsbury, Bristol) was allowed
throughout the study.
The animal room was maintained at a temperature of 18 - 22•c and
relative humidity of 55 - 64%. The rate of air exchange was
approximately 15 changes per hour and the lighting was controlled
by a time switch to give continuous 12 hours light and 12 hours
darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg/site moistened with an equal amount of Water

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

8

Reversibility:

other: not applicable

Remarks:

faint coloration by the test material was seen in 2 animals

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material, produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted .

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used follwed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in

Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites one hour after patch removal.

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material was also classified as non-irritant according to EEC labelling regulations.