Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study, for read-across justification refer to IUCLID section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF 8147
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (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
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
please refer to the confidential details of the test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight) 170-181 g ( on day 0)
- Fasting period before study:Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Makrolon cage, type III, single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes: approx. 10 per hour
- Photoperiod: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

IN-LIFE DATES: 2014-06-24 to 2014-07-09

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw/d (5.49 ml/kg bw undiluted substance)
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight determination:
Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations:
Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
Mortality:
A check for any dead or moribund animals was made at least once each workday
- Necropsy of survivors performed: yes
Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2- inhalation in a chamber with increasing concentrations over time.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed
Mortality:
No mortality occurred
Clinical signs:
Impaired general state and piloerection at hour 2 and 3 and on day 9 after administration was observed in one animal.
Body weight:
The body weight of all animals increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings.

Applicant's summary and conclusion