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: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 4 to 18 August, 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:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

yes

Remarks:

Fluctuations in optimal conditions of temperature and humidity, that do no not affect the study integrity.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

(1992)

GLP compliance:

yes

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 Ltd., Basel, SwitzerlandAge at study initiation: ca. 11 weeksWeight at study initiation: +/- 20 % of the sex meanNumber of animals: 5/sexHousing: 5 animals per sex per cageDiet: free access to standard pelleted laboratory animal dietWater: free access to tap waterAcclimation period: 5 days before start of treatment under laboratory conditionsEnvironmental conditionsTemperature: 21 °CHumidity: 55 %Air changes: air-conditioned with 15 air changes per hourPhotoperiod: 12 hours artificial fluorescent light and 12 hours dark per day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Dose volume: 10 ml/kg bw.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

5/sex.

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 daysMortality/viability: twice dailyBody weights: days 1 (pre-administration), 8 and 15Clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafterNecropsy of survivors performed: yes, after oxygen/carbon dioxide asphyxiation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

The only clinical sign noted was alopecia in the right cheek region among three males between days 7 and 15. This was considered a change with no toxicological significance.

Body weight:

The body weight gain shown by female animals over the first week and by males over the whole study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Slight body weight gain was noted in three females and body weight loss in one female over the second week.

Gross pathology:

Macroscopic post mortem examination of animals at termination revealed alopecia in the left ear region in one male only. Local alopecia is a common finding in animals of this age and strain and therefore considered not related to treatment.

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:

Oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/kg bw.

Executive summary:

Method

Single oral dose study in male and female rats by oral gavage at dose of 2000 mg/kg bw. Animals observed for 14 days after dosing.

Result

No mortality occurred and no significant changes in body weights and clinical signs were observed. LD50 value is greater than 2000 mg/kg bw.