Reaction mass of sodium 4-(4-acetamidophenylamino)-1-amino-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate and hydrogen 4-(4-acetamidophenylamino)-1-amino-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

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:

October 19, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

The endpoint was evaluated by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Blue 040 - Similar Substance 01

IUPAC Name:

Acid Blue 040 - Similar Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann
- Age at study initiation: 9 weeks old (Male), 14 weeks old (female)
- Weight at study initiation:
male: 161 - 175 g
female: 152 - 161 g
- Fasting period before study: 16 hours before
- Housing: group of 5 rats were housed in Makrolon cage type III with dust-free wood pellets
- Diet: Altromin R 1324, ad libitum.
- Water: tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5 °C
- Humidity (%):60 ± 5%
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark light from 7:00 to 19:00

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 ml/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 900 mg/kg bw

Based on:

act. ingr.

Mortality:

no mortality observed

Clinical signs:

other: no clinical signs observed

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 > 5000 mg/kg bw (3900 mg/kg bw based on active ingr.).

Executive summary:

The substance has been tested for acute toxicity by oral route to male and female Wistar rats. The LD50 was greater than 5000 mg/kg bw (3900 mg/kg bw based on active ingredient) for male and female rats.
There are no signs of intoxication.