[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

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:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Molecular formula:

C26H20.85Br1.82Na1.97N3O9S2

IUPAC Name:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Test material form:

other: solid

Details on test material:

None

Test animals

Species:

rat

Strain:

other: Tif. RAI rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: The rats were starved during one night before starting the treatment.
- Housing: The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): approximately 50

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

FAT 40069/A was suspended at 30 % with polyethylene glycol (PEG 400).

Doses:

-3170, 3590, 4000, 4640, 6000 and 7750 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Statistics:

The LD50 was calculated by probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 408 mg/kg bw

Based on:

test mat.

95% CL:

4 645 - 6 295

Mortality:

Yes

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 8 to 11 day

Gross pathology:

Autopsy in dead and killed animals: No substance related gross organ changes were seen.

Other findings:

None

Any other information on results incl. tables

Mortality:

Dose mg/kg	Concentration % of formulation	No of Animals		Died within
		m	f	m 1hr	f 1hr	m 24 hrs	f24 hrs	m 48 hrs	f 48 hrs	m 7 d	f  7 d	m 14 d	f 14 d
3170	30	5	5	0	0	0	0	0	0	0	0	0	0
3590	30	5	5	0	0	0	0	0	0	0	1	0	1
4000	30	5	5	0	0	0	1	0	1	0	1	0	1
4640	30	5	5	0	0	1	2	2	4	2	4	2	4
6000	30	5	5	0	0	3	4	3	4	3	4	3	4
7750	30	5	5	0	0	4	3	4	3	4	3	4	3
No higher dosed were possible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 40069/A in rats of both sexes observed over a period of 14 days is 5408 mg/kg (95 % confidence level 4645-6295 mg/kg).

Executive summary:

An acute oral toxicity was determined for FAT 40069/A using Tif. RAI rats (30 males and 30 females). Before administration by oral intubation, FAT 40069/A was suspended at 30 % with polyethylene glycol (PEG 400). The test material was administered at different doses (5 males and 5 females rats per dose): 3170, 3590, 4000, 4640, 6000 and 7750 mg/kg. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnea, exophthalmos, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 8 to 11 days. They were killed and autopsied after an observation period of 14 days.At autopsy no substance related gross organ changes were seen. Mortality were seen in group of rats with dose at 3590 mg/kg body weight and above. The mortality observed was 1/10, 1/10, 6/10, 7/10 and 7/10 at 3590, 4000, 4640, 6000 and 7000 mg/kg bw, respectively. In conclusion, the acute oral LD50 of FAT 40069/A in rats of both sexes observed over a period of 14 days is 5408 mg/kg (95 % confidence level 4645-6295 mg/kg). The compound has therefore a slight acute toxicity to the rat by this route of administration.