N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 August 2015 to 3 November 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

EC Number:

246-058-2

EC Name:

N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Cas Number:

24170-60-3

Molecular formula:

C19H19N7O5

IUPAC Name:

N-{2-[(2-cyano-4,6-dinitrophenyl)diazenyl]-5-(diethylamino)phenyl}acetamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Test material identified as: FAT36156/D TE

SOURCE OF TEST MATERIAL
- Batch number of test material:
20140804
- Expiration date of the lot/batch:
21 August 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RCCHan:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
8 to 12 weeks
- Weight at study initiation:
159 to 186 g
- Fasting period before study:
Overnight
- Housing:
in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
19 to 25
- Humidity (%):
30 to 70
- Air changes (per hr):
15
- Photoperiod (hrs dark / hrs light):
12 hours continuous light and 12 hours darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths found during the study period.

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period. However, green stained feces was noted in the initial treated animal on Days 1 to 6.

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

Individual Clinical Observations and Mortality Data

 

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 Female	0	0	0	0	0F	0F	0F	0F	0F	0F	0	0	0	0	0	0	0	0
	2-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-1 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-2 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-3 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0 =     No signs of systemic toxicity

F =      Green stained feces

 

 

Individual Body Weights and Body Weight Changes 

Dose Level mg/kg	Animal Number and Sex	Body Weight (g) at Day			Body Weight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Female	160	180	188	20	8
	2-0 Female	159	173	200	14	27
	2-1 Female	171	188	199	17	11
	2-2 Female	186	203	200	17	-3
	2-3 Female	164	176	180	12	4

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the FAT 36156/D in the female Wistar rat was estimated to be greater than 2000 mg/kg bw.

Executive summary:

FAT 36156/D was assessed for acute toxicity potential via ora route according to OECD Guideline 420 and EU Method B.1. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and no signs of systemic toxicity. However, green stained feces were noted in the initial treated animal. Animals showed expected gains in body weight, except for one animal which showed expected gain in body weight during the first week but body weight loss during the second week. No abnormalities were noted at necropsy. In conclusion, the acute oral median lethal dose (LD₅₀) of FAT 36156/D in the female Wistar rat was estimated to be greater than 2000 mg/kg bw.