Registration Dossier

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17th June 2016 - 12th Jul 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Appearance: yellow liquid
- Storage conditions of test material: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
6 young female adults (nulliparous and non-pregnant) were slected. Each dose group consisted of 3 animals. Prior to dosing, it was ensured that the animals were healthy and without any abnormality that may have affected the study integrity. Animals were group housed (3/cage) in labeled Makrolon cages containing sterilized sawdust as bedding material and paper as cage-enrichment. Rats were provided tap water and pelleted rodent diet ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test sample was administered as a single oral gavagae via plastic feeding tubes. Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test item. Water was available ad libitum
Doses:
2000 mg/kg bw/day
No. of animals per sex per dose:
3 femlaes /dose group
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.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occured
Clinical signs:
Piloerection and/or hunched posture were noted for three animals on Day 1
Body weight:
The mean body weight gain shown by the survivng animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain
Gross pathology:
No abnormalities were found at macroscopic post mortem examinations of the animals

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg body weight.
According to OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw/day.
Executive summary:

The test article was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15) No mortality occured. Piloerectiton and/or hunched posture were noted for three animals on Day 1. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examinations of the animals.

The oral LD50 was considered to exceed 2000 mg/kg.

According to OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw/day