N-alkylester N-aryl substituted aryl diazo aryl amine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 to 19 Dec 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to OECD 423 and GLP guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Name: DYNS 2246

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. Toxi Coop Ltd., 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: 8 weeks old
- Weight at study initiation: 187 g to 198 g
- Fasting period before study: over night until 3 hours post treatment
- Housing: Group caging (3 animals/cage)
- Diet): ssniff® SM R/M-Z+H ad libitum
- Water: tap water ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 23.1°C
- Humidity (%): 32 - 70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 05 December 2008 To: 19 December 2008

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: solubiltity in vehicle
- Lot/batch no. (if required): 1387867

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: test item was considered to have low toxicity based on experience with similar compounds

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: 30 minutes, 1, 2, 3, 4 and 6 hours after dosing on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no deaths occurred

Clinical signs:

other: no adverse effects

Gross pathology:

no test item-related findings

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item DYNS 2246 was greater than 2000 mg/kg body weight in female CRL:(WI) BR rats
DYNS 2246 was ranked into Category 5 of Globally Harmonized Classification System.

Executive summary:

The single-dose oral toxicity of DYNS 2246 was assessed according to the acute toxic class method (OECD 423, and Directive 2004/73/EC B.1.tris) in CRL: (WI) BR rats.

Two groups of three female CRL:(WI) BR Wistar rats (8 to 12 weeks of age) were treated with a solution of DYNS 2246 in Polyethylene-glycol 400 (PEG) at a dose level of 2000 mg/kg body weight (bw) by oral gavage (Group 1 and Group 2). DYNS 2246 was administered at a concentration of 200 mg/mL (Group 1 and Group 2) prepared in PEG 400, Ph Eur with a treatment volume of 10 mL/kg bw. Rats were fasted overnight prior to treatment. Rats were maintained without compound administration for a 2-week observation period after the day of dosing (Day 0). No mortality occurred after dosing with 2000 mg/kg bw, so treatment at lower dose levels was not required.

Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Food was made available again 3 hours after the treatment. Body weight was measured prior to dosing and weekly thereafter. Rats were euthanized and necropsied at the end of the 2-week observation period (Day 14).

Results

DYNS 2246 did not cause mortality at 2000 mg/kg bw:

Group:	Group 1	Group 2
Dose (mg /kg bw)	2000	2000
Number of animals	3	3
Mortality	0/3	0/3

No clinical signs were observed after the treatment with the test item or during the 14 day observation period.

Body weight gains of DYNS 2246 treated animals during the study showed no indication of a treatment-related effect.

A single oral gavage of DYNS 2246 to the CRL(WI)BR rats at a dose level of 2000 mg/kg bw followed by a 14 day observation period, was not associated with any test article-related macroscopic findings.

Conclusion:

Under the conditions of this study, the acute oral median lethal dose (LD₅₀) of the test item DYNS 2246 was greater than 2000 mg/kg body weight in female CRL:(WI) BR rats.

DYNS 2246 was ranked into Category 5 of Globally Harmonized Classification System.