N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw,

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

Study period:

October 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Two groups of anmilas; Group 1: 3 Females, Group 2: 3 mailes.
- Age at study initiation: young adult
- Weight at study initiation: 150-300 g
- Acclimatisation period: 1 week minimum
- A single oral treatment was given following 16 hours of food withdrawal.
- Housing: 1 animal per cage (stainless steel wire mesh). No bedding in cages, sawdust in waste trays.
- Diet: Kliba-Labordiaet.
- Water: Drinking tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Relative humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12-hour light/12 hour dark

STUDY TIME SCHEDULE
Dates of administration: 01.10.1997 (Group 1); 08.10.1997 (Group 2)

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE:
The test item was formulated at a concentration of 40g/100mL in the vehicle. 5ml/kg bodyweight were administered, resulting in a dose of 2000mg/kg. The stability of the test item in olive oil for a time period of 4 hours was confirmed by analysis. The homogeneity of the test substance preparation was also confirmed by analysis.

- Rationale for the selection of the starting dose:
The test procedure starting dose of 2000 mg/kg bw was selected. This was based on the physical and chemical characteristics of the substance, no pronounced acute oral toxicity was expected.
The test substance at this dose level was administered to one groups of three females.
No mortality was observed therefore a further confirmatory group of 3 male animals were treated at the dose level of 2000mg/kg bw.

No death of animals was observed and therefore the testing was finished.

On the night before treatment, animals were fasted (for 16 hours). Food was withheld, but not water. A single oral gavage administration was given in the morning.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Group 1: 3 females
Group 2: 3 males

Control animals:

no

Details on study design:

--Post exposure observation period:
A 14 day observation period followed.
- Frequency of observations and weighing:
- Body weight: Before application (Day 0), and weekly thereafter.
- Mortality: At least Daily
- Clinical observations were peformed on all animals several times on the day of administration and once per day for the 14 day observation period.

- Necropsy/Pathological examination: Carried out on the last day of the observation period following food withdrawal for 16 hours, before killing with CO2.
- Clinical signs, body weight, body weight gain and gross macroscopic data were recorded.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths: The test substance did not cause mortality at a dose level of 2000mg/kg bw.

Clinical signs:

Reddish coloured faeces were observed in all male animals on day 1. The female rats did not show any symptoms.

Body weight:

The expected body weight gain was observed in the course of the study with the exception of 1 female animal which showed stagnation of body weight in the second week of observation.

Gross pathology:

No abnormalities were noted at necroscopy.

Interpretation of results:

other: Not classified (EU criteria)

Conclusions:

Under the conditions of this study, the acute Oral LD50 value of the test substance was found to be above 2000mg/kg bw in male and female Wistar rats.

Executive summary:

The acute toxic effects of the test substance were assessed according to OECD Test Guideline 423.

The test substance was administered in a single dose as solution in vehicle (Olive oil), given orally via gavage to two groups of three rats (1 female group and 1 male group)

Initially, three females (Group 1) were treated at a dose of 2000mg/kg of body weight. As no mortality was observed a confirmatory group of male rats were treated at the same dose level.

The test substance administered at the dose of 2000 mg/kg caused no deaths in either group. The expected body weight gain was observed with the exception of 1 female animal. No abnormalities were noted upon pathology examination. The only clinical symptom observed was red faeces in male animals one day after application.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Reliability of 1, following OECD guideline and conducted according to GLP.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity.