Reaction mass of 1-amino-9,10-dioxo-4-(phenylamino)-9,10-dihydroanthracene-2-sulfonic acid and sodium 1-amino-9,10-dioxo-4-phenylaminoanthracene-2-sulphonate

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:

May 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The test was conducted 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:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Cycle dark/light 14 hours

GLP compliance:

no

Remarks:

pre GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Blue 025:1

IUPAC Name:

Acid Blue 025:1

Test material form:

solid: particulate/powder

Test animals

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

Administration / exposure

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:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

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 mg/kg bw : ditto laboured respiration, ataxia.

Body weight:

Dose 1000 mg/kg bw : 86 g (pre-test), 182 g (on day 15 of test)
Dose 3000 mg/kg bw : 84 g (pre-test), 179 g (on day 15 of test)
Dose 10000 mg/kg bw : 80 g (pre-test), 175 g (on day 15 of test)
Dose 15000 mg/kg bw :82 g (pre-test), 177 g (on day 15 of test)

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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.