3-pyridylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted in GLP compliance and in accordance with OECD Guideline No 420. Identity is not completely clear, therefore reliability 2

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3AP

IUPAC Name:

3AP

Test material form:

other: solid

Details on test material:

batch: 08Z359

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laberateries UK Limited, Bicester, Oxon, UK.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 160 - 182 g
- Fasting period before study: overnight
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/ml, 5 mg/ml, 0,5 mg/ml
- Amount of vehicle (if gavage): 10 ml /kg


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: ln the absence of data regarding the oral toxicity of the test material, 300 mg/kg was
chosen as the starting dose.

Doses:

300 mg/kg, 50 mg/kg, 5 mg/kg

No. of animals per sex per dose:

300 mg/kg: 1 female
50 mg/kg: 1 female
5 mg/kg: 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observations: 0,5, 1, 2, and 4 hours after dosing.Morbidity and mortality checks were made twice daily.
Individual bodyweights: Day 0 (the day of dosing) and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 - <= 50 mg/kg bw

Based on:

test mat.

Mortality:

5 mg/kg: no deaths
50 mg/kg: The animal was found dead approximately five and a half hours after dosing
300 mg/kg: The animal was found dead thirty minutes after dosing.

Clinical signs:

other: 5 mg/kg: No signs of systemic toxicity were noted du ring the observation period 50 mg/kg: Signs of systemic toxicity noted were hunched posture, occasional body tremors, increased salivation and pilo-erection. 300 mg/kg: No signs of systemic toxicity wer

Gross pathology:

5 mg/kg: No abnormalities were noted at necropsy.
50 mg/kg: Abnormalities noted at necropsy were abnormally red lungs, dark liver, dark kidneys and slight haemorrhage of the non-glandular region of the stomach.
300 mg/kg: No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

Category 2 based on GHS criteria

Conclusions:

The acute oral median Iethal dose (LD50) of the test material in the female Wistar strain
rat was estimated to be in the range of 5 - 50 mg/kg bodyweight (Globally Harmonised
Classification System- Category 2) in this study.
This study is not used for GHS classification of the substance, because at the critical dose of 50 mg/kg only one rat was tested. For Acute Oral Toxicity classification the H-phrase H301 of another study was taken. This study is more reliable because 10 rats were tested with 50 mg/kg.