trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 12, 1998 to January 15, 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-280-3

EC Name:

-

Cas Number:

844491-96-9

Molecular formula:

Hill formula: C19H16N3Na3O13S4

IUPAC Name:

lithium(1+) disodium 4-hydroxy-6-[(sulfonatomethyl)amino]-5-(2-{2-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate

Test material form:

solid

Remarks:

black-brown

Details on test material:

Reactive Red 1997

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Chbb:NZW(SPF)

Details on test animals or test system and environmental conditions:

Source: Boehringer Ingelheim Pharma KG, Birkendorferstrasse 65, D-88397 Biberach/Riss
Number of animals: 1 male, 2 females
Age at start of treatment: 15 weeks
Identification: by unique cage number and corresponding ear number
Acclimatization: Four days under test conditions after health examination.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: The dorsal fur was clipped with an electric clipper.

Vehicle:

other: The test substance was moistened with bi-distilled water before application.

Amount / concentration applied:

Soli 0.5 g /animal (left side only)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Approximately three days before treatment the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100m2 (10cm x 10 cm). The skin of the animals was examined approximately 24 hours before treatment and if necessary regrown fur was again clipped.

On the day of treatment the test substance was applied to approximately 6cm2 of the intact skin of the clipped area. It was covered with a 25 cm x 25 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

The duration of the treatment was 4 hours. Then the dressing was removed and the skinwas flushed with lukewarm tap water to clean the applicationsite so that any reactions (erythema) were clearly visible at that time.

Observations
Mortality/ viability: daily
Clinical signs: daily during the observation period
Body weights: a start of acclimatization, in the first day of application and at termination of observation

Irritation scores
The skin reaction was assessed according to the numerical scoring system listed in the EEC Comission Directive 92/69/EEC, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing gaze patch and test substance.

Pathology
No necropsy was performed in the animals acrifficed at termination of observation. All rabbits were sacrifices by an intravenous injection of Narcoren into the ear vein of at least 1 ml/kg body weight.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Application of the test substance to healthy intact rabbit skin resulted in a primary irritation score of 0.00. Local signs consisted of grade 0.00 edema (mean values from 24 to 72 hours) and grade 0.00 erythema (mean values from 72 hours).
Violet-red staining by the test substance o the treated skin was observed.
No corrosive effect and no irreversible alterations of the treated skin were observed.

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The body weight of all rabbits was considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was considered to be not irritating to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. The primary skin irritation potential of the test substance was investigated by topical application of 0.5 g to 6 cm2 of intact dorsal skin of each of three young adult New Zealand White rabbits. The duration of the treatment was 4 h. The scoring of skin reactions was performed at 1, 24, 48 and 72 h after removal of the dressing. The scores of each animal at 24, 48 and 72 h were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48, 72 h and then dividing by the number of data points. The primary irritation score was 0.00 (max. 8.0). Local signs consisted of grade 0.00 oedema (mean values from 24 to 72 h) and grade 0.00 erythema (mean values from 72 h). The test substance caused violet-red staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Under the study conditions, the test substance was considered to be not irritating to rabbit skin (Braun, 1998)..