4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 18 October 2000 and 08 November 2000.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide

EC Number:

260-152-0

EC Name:

4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide

Cas Number:

56396-10-2

Molecular formula:

C25H20N4O4

IUPAC Name:

4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide

additive 1

Reference substance name:

Calcium abietate

EC Number:

236-677-6

EC Name:

Calcium abietate

Cas Number:

13463-98-4

Molecular formula:

C20H30O2.1/2Ca

IUPAC Name:

calcium bis((1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate)

Test material form:

solid: particulate/powder

Details on test material:

An additive (CAS 13463-98-4) was present in the sample, at 10 % w/v

Specific details on test material used for the study:

Sponsors identification: ST383
Description: red powder
Batch number: S/No. 8793
Date received: 12 September 2000
Storage conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: ca. 8 weeks of age
- Weight at study initiation: Males = 225-246 g and Females = 204-216 g
- Fasting period before study: Overnight fast immediately before dosing
- Housing: housed in groups of 3 by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No.1, Special Diets Services Ltd., Witham, Essex, UK (ad libitum)
- Water (e.g. ad libitum): drinking water (ad libitum)
- Acclimation period: >=5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): >=15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

All animals were dose onced only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each sex to confirm the survival of the previously dosed animals.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 animals per sex per dose (3 males at 2000 mg/kg and 3 females at 2000 mg/kg).

Control animals:

no

Details on study design:

The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsquently once daily for fourteen days.

Individual bodyweights were recorded prior to dosing and 7 and 14 days after treatment.

At the end of the observation period the animals were killed cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examinations and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalties was recorded. No tissues were retained.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Pink staining of the fur was noted in all females one and two days dosing and in all males one to four days after dosing. No other signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD^(R) (SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight.

No mortalies were noted in animals treated with 2000 mg/kg bodyweight.

Executive summary:

Introduction. The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD (Crl: CD^® (SD) IGSBR) strain rat. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996)
• Commision Directive 96/54/EC Method B1 tris Acute Toxicity (Oral) - Acute Toxic Class Method

Method. A group of three fasted females was treated with 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level.

The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy examination.

Mortality. There were no deaths.

Clinical Observations. Pink staining of the fur was noted in all animals one to four days after dosing. There were no other signs of systemic toxicity.

Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy. No abnormalities were noted at necropsy.

Conclusion.The acute oral median lethal dose (LD₅₀) of the test material in the Sprague-Dawley CD (Crl: CD^®(SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight. No mortalities were noted in animals treated with 2000 mg/kg bodyweight.