Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

well performed guideline study according to OECD 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

EC Number:

279-091-6

EC Name:

Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

Cas Number:

79135-90-3

Molecular formula:

C24H18N6O18S3.3Na

IUPAC Name:

trisodium 3-({4,6-bis[(3-carboxy-2-hydroxy-5-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-5-carboxy-4-hydroxybenzene-1-sulfonate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Kleintierfarm Madoerin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 kg to 3.0 kg
- Housing: Individually in stainless steel cages equipped with an automatic drinking water supply and cleaning system
- Diet (e.g. ad libitum): standard rabbit maintenance feed Kliba 23/341/1, Klingentalmuehle AG ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 2°C (air-condition)
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Polyethyleneglycol 400/saline (70:30)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 %

VEHICLE
- Amount(s) applied (volume or weight with unit):1.0 ml to moisten the test item
- Lot/batch no. (if required): Ch-B 2322 , Riedel de Haen AG
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

4 hours

Observation period:

3 days

Number of animals:

3 (2 females, 1 male)

Details on study design:

Before Treatment the entire back and the flank of the rabbits were closely clipped with electric clippers. Application was made to the intact skin site on the clipped dorsum of each rabbit.

TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch, covered with aluminium foil; trunk of the animals was wrapped with an occlusive bandage of elastic adhesive dressing.

- Time after start of exposure: 4 hours

SCORING SYSTEM:
the condition of the intact skin site was observed at 1, 24, 48, and 72 h following removal of bandage and gauze patch, unless the skin is normal at 7 or 14 days; assesment according to Draize J.H.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of three animals

Time point:

other: after 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects occured

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of three animals

Time point:

other: after 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects occured

Irritant / corrosive response data:

no destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that no corrosion effect had occured on the skin.

Other effects:

In the area of application no coloration of the skin was observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a OECD guideline compliant primary skin irritation test in rabbits neither erythema nor edema were observed 1, 24, 48 and 72 hours after application of the test substance. Therefore, the test item has to be regarded as not irritating to skin.

Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. No effects were observed after occlusive application of a 50 % solution in PEG/saline (70:30) of 0.5 g to the intact skin of each of three young adult New Zealand White rabbits. The duration of treatment was four hours.

The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. No destructions, irreversible/reversible alterations or coloration of the treated skin were observed at any animal at any measuring interval.

Thus, the test item did not induce significant or irreversible damage to the skin.

Therefore, the test item has not to be classified as "skin irritation" according to Regulation (EC) 1272/2008.