Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test procedure cannot be subsumed under a testing guideline, nevertheless are scientifically acceptable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Acute percutaneous toxicity test.
The acute dermal toxicity of the test item was investigated in male rats, in a 40 % of aqueous gum tragacanth. 12.5 ml of the substance was spreaded dermally and covered with an aluminum foil. After the exposure time of 24 hours, mortalities, signs of toxicity and dermal toxicity were observed.

GLP compliance:

no

Remarks:

Pre GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate

EC Number:

248-420-5

EC Name:

Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Cas Number:

27344-06-5

Molecular formula:

C42H46N14O10S2.2Na

IUPAC Name:

disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 229 - 249 g.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: aqueous gum tragacanth (0.5 %)

Details on dermal exposure:

TEST CONCENTRATION
- Dose concentration: 12.5 ml/kg at 40 % of substance.

TEST SITE
- Area of exposure: dorso-lumbar region, 10 % of the total body surface.
- Hair removing method: electric clippers. No shaving or chemical depilation.
- Day of the preparation: one day prior to treatment.
- Type of wrap if used: with "Sleek" waterproof plaster, firmly round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing with warm diluted soap solution (40-50 °C), rinsing in clean warm water and blotting dry with absorbent paper.

Duration of exposure:

24 hours.

Doses:

0 and 5000 mg/l.

No. of animals per sex per dose:

5 males per dose.

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days.
- Observations: daily, for signs of of dermal irritation, according to the scoring system. All animals were sacrificed terminally and examined macroscopically in an attempt to identify any target organs.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortalities were found.

Clinical signs:

other: No signs of toxicity were observed.

Gross pathology:

Normal.

Other findings:

No dermal reactions were observed.

Any other information on results incl. tables

Results

Sex	Dosage level	Body weight (g) at			Mortality
Male	(g/kg)	Dosing	1 week	2 weeks
	0	249	327	382	0/5
	5	243	270	318	0/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP regulation Criteria used for interpretation of results: EU

Conclusions:

LD50 (percutaneous) > 5000 mg/l, non toxic.

Executive summary:

Method

The acute dermal toxicity of the test item was investigated in male rats, in a 40 % of aqueous gum tragacanth. 12.5 ml of the substance was spreaded dermally and covered with an aluminum foil. After the exposure time of 24 hours, mortalities, signs of toxicity and dermal toxicity were observed.

Results

The percutaneous LD50 was > 5000 mg/l, therefore the test item could be considered non toxic.