1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

Data is from study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of test chemical in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide

EC Number:

229-313-2

EC Name:

3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide

Cas Number:

6471-49-4

Molecular formula:

C24H17N5O7

IUPAC Name:

3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide

Test material form:

solid: particulate/powder

Details on test material:

IUPAC Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamid
Common Name: Pigment Red 23
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Smiles: c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1) [N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
Name of test material (as cited in study report):TK-11451
Molecular formula:C24H17N5O7
Molecular weight: 213.2349 g/mol
Substance type:Organic
Physical State: Solid

Test animals

Species:

rat

Strain:

other: Tif. RAI rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: Animals were weighed 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.
- Diet (e.g. ad libitum): food, ad libitum.
- Water (e.g. ad libitum): water, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1° C
- Humidity (%): approximately 50 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 and 60 %
DOSAGE PREPARATION (if unusual): Test material was suspended at 50 and 60 % with carboxymethylcellulose 2 % and administered by oral intubation.

Doses:

6000 and 10000 mg/kg

No. of animals per sex per dose:

Total = 20 (sex/dose)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Mortality and general symptoms was observed at 1 h, 24 h, 48 h, and 7 days.
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for clinical signs.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

No mortality was observed at 10000 mg/kg bw.

Clinical signs:

Within 2 hours after treatment the rats of both dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. The animals had recovered within 4 to 6 days.

Body weight:

not specified

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

not specified

Any other information on results incl. tables

Table – Results

Dose mg/kg	Concentration % of Formulation	No. of animals		Deaths Within
				1 hr.		24 hr.		48 hr.		7 days
		♂	♀	♂	♀	♂	♀	♂	♀	♂	♀
6000	50	5	5	0	0	0	0	0	0	0	0
10000	60	5	5	0	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The LD50 was considered to be >10000 mg/kg bw, when Tif. RAI rats were treated with test chemical via oral gavage route.

Executive summary:

Acute oral toxicity test was conducted using test chemical in 20 Tif. RAI rats (10 males/10 females), bred under SPF conditions at the dose concentration of 6000 and 10000 mg/kg bw. The test substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 50 and 60 % 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. Mortality and general symptoms was observed at 1 h, 24 h, 48 h, and 7 days.Animals were observed for clinical signs. No mortality was observed at any of the dose in treated rats. Within 2 hours after treatment the rats of both dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. The animals had recovered within 4 to 6 days.They were killed and autopsied after an observation period of 7 days. No substance related gross organ changes were seen. Hence, LD50 was considered to be >10000 mg/kg bw, when Tif. RAI rats were treated with test chemical via oral gavage route.