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Diss Factsheets

Administrative data

Description of key information

Acute Oral Toxicity
The study was conducted in accordance wilth under Annex V of the EEC direcetíve 79/831/EEC, Part B Methods for determínation of toxicity, Method B1 Acute OraI Toxicity, and the OECD guideline for Testing of Chemicals No. 401 "Acute OraI Toxicity"

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 400 mg/kg bw

Additional information

Acute Oral Toxicity

Mortality: There was a single male death amongst rats dosed at 0.80 g a.i/kg and deaths amongst both sexes of rat treated at 1.26 g a.i./kg and above. The majority of rats died from within six hours of dosing until Day 4. A single male, treated at the low dose Ievel, was found dead on Day 10.

Autopsy of rats that died commonly revealed no macroscopic abnormalities. The only exception was the presence of brown Iiquid within the urinary bladder of a single male dosed at 2.00 g a.i./kg.

Clinical signs: Common signs of reaction to treatment within four hours of dosing were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), Iethargy, decreased respiratory rate, ptosis, pallor of the extremities, increased salivation and prostration. Other clinical signs apparent at the same time or at later intervals on Day 1 were:

- ataxia amongst rats treated at all dose levels,

- increased lachrymation amongst females dosed at 0.80 g .i./kg and in all rats treated at 1.26 and 2.00 g.a.i/kg.

Recovery of rats surviving treatment, as judged by external appearance and behaviour, was apparently complete by Days 4 and 5 (0.80 and 1.26 g a.i./kg) or Day 7 (2.00 g a.i./kg).

Delayed signs of toxicity including pilo-erection , abnormal body carriage, abnormal gait, lethargy and pallor of the extremities reappeared on Day 9 in one male dosed at 0.80 ga.i./kg and preceded death on the following day.

Bodyweight: Low bodyweight gains during the first week of the study were recorded for all surviving rats.

Single male and female rats dosed at 0.80 and 1.26 g a.i./kg and a further male treated at the high dose level showed low bodyweight, gains between Days 8 and 15.

Terminal autopsy findings were normal


Justification for selection of acute toxicity – oral endpoint
reliable study available

Justification for classification or non-classification

Acute Oral Toxicity

The acute lethal oral dose was found between 200 and 2000 mg a.i./kg bodyweight

It is concluded that butyl benzotriazol, sodium salt has to be classifiedhas harmful with risk phrase R22 (DSD) and Acute Tox. 4 with hazardous Statement H302 (CLP/GHS)