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

Endpoint summary

Description of key information

Acute oral toxicity: 

Acute oral toxicity dose (LD50) for 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no:6471-49-4) was considered based on Sustainability Support Services (Europe) AB > 10000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no:6471-49-4) has very low vapour pressure (5E-17 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.

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

Reliability:

1 (reliable without restriction)

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.

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (6471-49-4) in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

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 (if other than submission substance):C24H17N5O7
- Molecular weight (if other than submission substance):213.2349 g/mol
- Substance type:Organic

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 %

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:

No data

Preliminary study:

No data

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:

other: 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.

Gross pathology:

No substance related gross organ changes were seen.

Other findings:

No data

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

 

Interpretation of results:

other: Not classified

Conclusions:

The LD50 was considered to be > 10000 mg/kg bw, when Tif. RAI rats were treated with 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (6471-49-4) via oral gavage route.

Executive summary:

Acute oral toxicity test was conducted using 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (6471-49-4) 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 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide via oral gavage route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

Data is Klimisch 1 and from experimental report.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

In an experimental study conducted by Sustainability Support Services (Europe) AB has letter of access (Report No. Siss 3118, 1973) was designed and conducted using 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (6471-49-4) 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 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide via oral gavage route.

Thus, based on the above study on 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no:6471-49-4), it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide cannot be classified for acute oral toxicity.

 

Acute Inhalation Toxicity:

3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no:6471-49-4) has very low vapour pressure (5E-17 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.

Justification for classification or non-classification

Based on the above study on 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no:6471-49-4), it can be concluded that LD50 value is greater than 2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide cannot be classified for acute oral toxicity.

For Acute Inhalation toxicity wavier were added so, not possible to classify.