sodium 5-(4-amino-6-(4-((E)-4-(4-(bis(2-hydroxyethyl)amino)-6-(8-hydroxy-7-((E)-phenyldiazenyl)-3,6-disulfonatonaphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatostyryl)-3-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-((E)-phenyldiazenyl)naphthalene-2,7-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1994-10-25 and 1994-11-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

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 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Direct Red 227:1 – Similar Substance 01

IUPAC Name:

Direct Red 227:1 – Similar Substance 01

Test material form:

not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, U.K.
- Age at study initiation: approx. 5 to 8 weeks
- Weight at study initiation: males 150 - 160 g, females 148 - 166 g
- Fasting period before study: overnight fast immediately before dosing, approx. 2 h after dosing
- Housing: housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: rat and mouse expanded diet no. 1, special diets services limited, Witham, Essex, U.K., ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 48 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 mg/kg

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: observations: 1/2, 1, 2 and 4 hours after dosing, subsequently once daily; weighing: before experiment, on day 7 and 14
- range-finding study was performed to define the dose level for the main study
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight

Statistics:

not required

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

act. ingr.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systematic toxicity were noted during the study. Dark red staining of the fur was noted in all males from 1-hour observation to the day 1 observation, and in one female at the 4-hour and 1 day observations.

Gross pathology:

No abnormalities were noted at necroscopy.

Applicant's summary and conclusion

Interpretation of results:

other: GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

An acute oral toxicity study was perfomed by using Sprague-Drawley strain rats. Based on the results of the range-finding study, the test substance (49 % act. integr.) was administered by gavage to 5 animals per 5 sex in doses of 2000 mg/kg bw. The animals were observed for mortality and signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. The results indicated no deaths. No signs of systemic toxicity were noted during the study. Dark red staining of the fur was noted in all males from the 1 -hour observation to the day 1 observation, and in one female at the 4 -hour and 1 day observations. Individual bodyweights were recorded prior to dosing on Day 0 and on Day 7 and 14. All animals showed expected gain in bodyweight during the study. No abnormalities were noted necropsy. The acute oral LD50 of the test material in rats was found to be greater than 2000 mg/kg bw.