Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-12-23 - 2017-01-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
other: CD / Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 180 - 207 g
- Fasting period before study: 16 hours before administration
- Housing:in groups of 3 animals in MAKROLON cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:At least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil/Ethanol
Details on oral exposure:
Administration volume 20 mL/kg b.w.

Doses:
Dose level 2000 mg/kg b.w. (limit test)
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no
Body weight:
no
Gross pathology:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, a single oral administration of 2000 mg Ukanol FR 70/kg b.w. did not reveal any signs of toxicity. All animals gained the expected body weight. No animal died prematurely. No pathological changes were observed at necropsy.
LD50 value: > 2000 mg Ukanol FR 70/kg b.w.
According to the EC Regulation 1272/2008 and subsequent regulations, the test material does not require classification for acute oral toxicity.
Also according to the Globally Harmonized Classification System (GHS) the test item requires no labelling (as LD50 > 2000 mg/kg b.w.).
Executive summary:

Under the present test conditions, a single oral administration of 2000 mg Ukanol FR 70/kg b.w. did not reveal any signs of toxicity.All animals gained the expected body weight.No animal died prematurely.No pathological changes were observed at necropsy.

LD50value:         > 2000 mg Ukanol FR 70/kg b.w.

According to the EC Regulation 1272/2008 and subsequent regulations, the test material does not require classification for acute oral toxicity.

Also according to the Globally Harmonized Classification System (GHS) the test item requires no labelling (as LD50> 2000 mg/kg b.w.).