Registration Dossier

Administrative data

Description of key information

Acute oral LD50 > 2000 mg/kg bw (BASF, 1988)

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DR. K. Thomae GMBH, D-7950 Biberach, FRG
- Weight at study initiation: males 181 g and females 192
- Fasting period before study: food depreviation 16 hours before test substance administration (water was available ad libitum).
- Housing: Five animals per stainless steel wire mesh cages, DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba labordiaet 343, Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland, ad libitum.
- Water: tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Justification for choice of vehicle: test substance is insoluble in water.

MAXIMUM DOSE VOLUME APPLIED:
5 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of test substance administration (at least once each workday). Check for moribund and dead animals twice each workday and once on public holidays.
- Necropsy of survivors performed: yes, sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die as soon as possible.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
No abnormalities observed.
Body weight:
Males: 181 g at study start, 279 g after 13 days
Females: 192 g at study start, 238 g after 13 days
Gross pathology:
No pathological findings noted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral

An acute oral toxicity study was performed with 5 Wistar rats per sex/dose. The animals were dosed with 2000 mg/kg bw test substance by oral gavage. The animals were observed for 14 days. No mortality or clinical signs were observed. The body weight of the animals increased during the 14 day observation period. Pathology showed no abnormalities. Under the conditions of the test the LD50 was determined to be > 2000 mg/kg bw (BASF, 1988).


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

Justification for classification or non-classification

Based on the available data, the substance does not have to be classified for acute oral toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.