Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 March 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)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

279-365-5

EC Name:

Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

80010-51-1

Molecular formula:

C29H28Cl2N4O7S.Na

IUPAC Name:

sodium 1-amino-4-[(3,5-bis{[(chloroacetyl)amino]methyl}-2,4,6-trimethylphenyl)amino]-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

FAT 210 36/A

Specific details on test material used for the study:

Name: 21036 / A
Purity: 79.9 %

Test animals

Species:

rat

Strain:

other: Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

The compound was tested on 40 Tif. .RAI rats (20 males/20 females), bred under SPF conditions in our own breeding unit. They were 6 to 7 weeks old and weighed 160 to 180 g. The males and females were segregated and housed in Macrolon cages (Type 3) in groups of 5 in a room kept at a constant temperature of 22 ± 1 °C and a relative humidity of approximately 50 %. They received water and food (NAFAG, Gossau SG, rat food) ad libitum. The rats were starved during one night before starting the treatment.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

1000, 3170, 4640 and 6000 mg/kg

No. of animals per sex per dose:

5 male and 5 females

Control animals:

no

Details on study design:

FAT 21036/A was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 10 and 30 % with carboxymethylcellulose 2 % and administered by oral intubation. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal was found dead in 6000 mg/kg group.

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 4 to 6 days

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

No further abnormalities reported.

Any other information on results incl. tables

Mortality:

Dose mg/kg	Concentration % of formulation	No of Animals		Died within
		m	f	m 2hr	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
1000	10	5	5	0	0	0	0	0	0	0	0	0	0
3170	30	5	5	0	0	0	0	0	0	0	0	0	0
4640	30	5	5	0	0	0	0	0	0	0	0	0	0
6000	30	5	5	0	1	0	1	1	1	1	1	1	1
No higher dosed were possible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 21036/A in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg.

Executive summary:

The acute oral toxicity of FAT 21036/A was assessed using Tif. RAI rats in a study conducted using methodology similar to OECD Guideline 401. FAT 21036/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): 1000, 3170, 4640 and 6000 mg/kg. 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 4 to 6 days. No substance related gross organ changes were seen at the post mortem examination. In conclusion, the acute oral LD50 of FAT 21036/A in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg. The compound therefore is non-toxic to the rat by this route of administration.