disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2 to 23 December, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test conducted according to internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1992)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Version / remarks:

(1992)

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 GS 3848

IUPAC Name:

Red GS 3848

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animalsSource: BRL, Biological Research Laboratories Ltd., SwitzerlandAge at study initiation: 10 weeks (males); 12 weeks (females)Weight at study initiation: 263.9 - 272.9 g (males); 198.6 - 209.9 g (females)Housing: during acclimatation in groups of 5 animals per cage; during treatment and observation period individually in cages.Diet: ad libitumWater: ad libitumAcclimation period: one week under laboratory conditions, after health examination. Only animals without any visual signs of illness were used for the studyEnvironmental conditionsTemperature: 22 ± 3 °CHumidity: 40 - 70 %Air changes: 10 - 15 per hourPhotoperiod: 12 hours artificial fluorescent light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

Test siteArea of exposure: back of the animals, 10 % of the total body surfaceType of wrap: dressing wrapped around the abdomenRemoval of the test substanceWashing: lukewarm tap waterTime after start of exposure: 24 hoursTest materialAmount applied: 4 ml test article dilution / kg body weight

Duration of exposure:

24 hours.

Doses:

2000 mg/kg body weight.

No. of animals per sex per dose:

5.

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days Frequency of observations and weighing: on test day 1 (pre-administration), 8 and 15Necropsy of survivors performed: yesOther examinations performed: mortality, clinical signs, body weight, macroscopic findings

Statistics:

The LOGIT-Model could not be applied, as no deaths occurred.

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 occurred during the study period.

Clinical signs:

No clinical signs of systemic toxicity were observed during the observation period. The only local alteration of the skin noted at the application site was red discoloration of the skin (5/5). This was evident after removal of the dressing on observation day 2 in all animals and persisted until study termination.

Body weight:

Minimal to slight loss of body weight (-3.2 and -0.4 g) was noted in one male and one female animal (no. 1 and no. 10) during the first observation week. The other animals gained weight throughout the observation period.

Gross pathology:

The macroscopic examination at study termination revealed no organ abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationaccording to the CLP Regulation (EC 1272/2008)Criteria used for interpretation of results: EU

Conclusions:

The mean lethal dose after single dermal administration in rats of both sexes, observed over a period of 14 days, could not be estimated because no deaths occurred at the maximal dose of 2000 mg/kg.

Executive summary:

Method

Study in male and female rats by dermal application at a single dose of 2000 mg/kg bw. Animals observed for 14 days after dosing.

Result

No mortality occurred and no clinical signs of systemic toxicity were observed. The test article stained the skin of the animals red at the application site. The slight loss of body weight in one male and one female animal during the first observation week was considered to be a consequence of the semi-occlusive dressing. The macroscopic examination at study termination revealed no organ abnormalities. The LD50 value is greater than 2000 mg/kg bw.