Sodium 1-amino-9,10-dioxo-4-phenylaminoanthracene-2-sulphonate

Endpoint summary

Description of key information

LD50(oral) > 15000 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:

experimental study

Adequacy of study:

key study

Study period:

May 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline available

Principles of method if other than guideline:

Similar to OECD Guideline 401 (Acute Oral Toxicity) with slight deviations (Cycle dark/light 14 hours).

GLP compliance:

no

Remarks:

pre GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Tif: RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Basle, Toxicology/Pathology PH 2.634/CP/gk
- Weight at study initiation: Mean initial body weight: from 80 to 86 grams
- Housing: group of 5 into Macrolon cages (Type 3)
- Diet (e.g. ad libitum): ad libitum Pellets n. 890 Nafag Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±1 °C
- Humidity (%): 55 ±5 %
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 %, 30 %, 25 %

Doses:

1000, 3000, 10000 and 15000 mg/kg bw

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Pre-mortem: Dose 1000 mg/kg bw: after 30 minutes hyperreflexia Dose 3000 mg/kg bw : ditto, after 15 minutes irregular respiration reduction in spontaneous motility, muscolar hypotonia. Dose 10000 mg/kg bw : ditto stiff movements, piloerection. Dose 15000

Gross pathology:

Dose 1000 mg/kg bw : no gross organ changes observed

Other findings:

Post-mortem:
Dose 1000 mg/kg bw: no gross organ changes observed
Dose 3000 mg/kg bw : no findings
Dose 10000 mg/kg bw : blue coloured skin
Dose 15000 mg/kg bw : no findings

Acute oral toxicity in the rat of Acid Blue 025

Dose (mg/kg bw)	Concentration (%)	mortality				Bodyweight (g)		Symptoms and necropsy
		absolute		day of test	n	pre-test	on day 15 of test
		m	f
1000	10	0/5	0/5			86	182	After 30 min. hyperreflexia lasting >6 hours. After 24 hours no symptoms. At autopsy no gross organ changes were seen.
3000	30	0/5	0/5			84	179	Ditto, after 15 min. irregular respiration, reduction in spontaneous motility, muscular hypotonia. Symptoms lasting >24 hours. After 3 days no symptoms,
10000	25	0/5	0/5			80	175	Ditto, stiff movements, piloerection. At autopsy, blue-coloured skin.
15000	25	0/5	0/5			82	177	ditto, laboured respiration, ataxia. Symptoms lasting >5 days. After 7 days no symptoms.

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 > 15000 mg/kg bw

Executive summary:

The substance has been tested in rat of both sexes. The animals were observed over a period of 15 days after a single administration of the test item (1000, 3000, 10000 and 15000 mg/kg bw) by oral intubation. The test substance shows a LD50 > 15000 mg/kg bw therefore is relatively innocuous to the rat by oral administration. No mortality was observed during the test period.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

15 000 mg/kg bw

Quality of whole database:

Method equivalent or similar to guidelines internationally accepted.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The substance was tested in 1977 by oral administration. The results of the test show a very high value of LD50. No death occurred during the test.

Justification for classification or non-classification

According to the CLP Regulation (EC) n. 1272/2008, acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

The substance is not classified according to table 3.1.1 of the CLP Regulation (EC) n. 1272/2008.