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Administrative data

Description of key information

LD50, Oral, Rat: 300mg/kg<LD50<2000mg/kg.

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:
05 March 2013 - 09 April 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD test guidelines and in compliance with GLP guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Specific details on test material used for the study:
Description: Brown Liquid
Batch: 12D25
Purity: 94.0%
Expiry Date: 30 January 2014
Storage Conditions: Room temperature in the dark
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Testing facility
- Age at study initiation: 8-12 weeks
- Fasting period before study: Overnight fast, immediately before dosing and for approximately three to four hours after dosing
- Housing: Housed 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 5 days

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

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg for 300 mg/kg group. 2000 mg/kg group recieved test material as supplied, dose volume (2.08 mL/kg) was based on the specific gravity (0.976) of the test material.

Doses:
300 mg/kg (following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg)
No. of animals per sex per dose:
Main study (300 mg/kg): 4
Total (including sighting study): 6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: 1/2, 1, 2, and 4 hours after dosing and then daily for up to 14 days;
weighing: on Day 0 (the day of dosing) and on Days 7 and 14 or at death (Individual body weights were recorded).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, macroscopic observations
Statistics:
The animal treated at a dose level of 2000 mg/kg was found dead one day after dosing. There were no deaths at a dose level of 300 mg/kg.
Preliminary study:
Dose Level - 2000 mg/kg:
- The animal was found dead one day after dosing,
- Hunched posture and ataxia were noted,
- No body weight gain was noted,
- At necropsy dark liver and epithelial sloughing of the gastric mucosa were noted

Dose Level - 300 mg/kg:
- There were no deaths,
- Hunched posture was noted in the initial treated animal,
- All animals showed expected gains in body weight over the observation period,
- No abnormalities were noted at necropsy.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity were noted in the additional four treated animals
Gross pathology:
No abnormalities were noted at necropsy.
Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
One study is available, conducted according to OECD test guidelines and in compliance with GLP.

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The LD50 for acute oral toxicity was found to be between 300 and 2000mg/kg. On this basis the substance is classified as Acute Category 4 for oral toxicity according to the CLP Regulation.