Tetrasodium 2,2''-diamino-8,8''-dihydroxy-4',4'''-{4-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,6-diyldiimino}bis(naphthalene-1-azobenzene-2',6-disulfonate)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 12th to July 3rd, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Red LF 6339

IUPAC Name:

Red LF 6339

Test animals

Species:

rat

Strain:

other: HanBrl: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division CH-4414 Fullinsdorf
- Age at study initiation: 8 weeks (males); 13 weeks (females)
- Housing: in groups of five per sex in Markrolon type-4 cages with standard softwood bedding during acclimation. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Fullinsdorf ad libitum
- Acclimation: under laboratory conditions after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30-70 %
- Air changes: 10-15
- Photoperiod: 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on dermal exposure:

TEST SITE
- Preparation of test area: one day before the treatment, the backs of the animals were clipped with an electric clipper
- Area of exposure: back of the animals. Applied evenly with a syringe
- % coverage: 10 % of the total body surface
- Type of coverage: the dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml

VEHICLE
- Lot/batch no. (if required): 433337/1 20602

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: daily during acclimatization and twice daily during days 1-15
- Frequency of weighing: on test days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes. macroscopic examinations
- Other examinations performed: clinical signs - daily during acclimatisation and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occured

Clinical signs:

no systemic or local signs of toxicity
A red discoloration of the treated skin area produced by the test item was noted was noted in all animals immediately after removal of the dressing and persisted until test day 5

Body weight:

within the range commonly recorded for this strain and age

Gross pathology:

no macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) No.1272/2008

Conclusions:

LD50 (male, female) > 2000 mg/kg bw