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

Endpoint summary

Description of key information

LD50 > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

No symptoms has been registered and no mortality has been observed in all studies. The LD50 is higher than 3900 mg/kg b.w, therefore no classification for acute toxicity oral is warranted under the CLP Regulation (EC n. 1272/2008).