Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-03-01 to 2016-03-18
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 (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 9-10 weeks old
- Weight at study initiation: 160-174 g
- Fasting period before study: Prior to the administration food was withheld from the test animals for 16 to 19 hours. Food was provided again approximately 4 hours post dosing.
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: food, ad libitum
- Water: water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg body weight.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Step 1: 3 females
Step 2: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on days 1, 8 and 15. Clinical examinations were made at 30 min, 4 hours post-administration, then daily until the end of the study observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and macroscopic examinations at necropsy

Results and discussion

Preliminary study:
Following oral administration of 2000 mg/kg bw test substance to 3 female rats, no mortality occurred and no clinical signs of toxicity were observed in any of the animals.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the 14-day study period.
Clinical signs:
No signs of clinical toxicity were observed during the 14-day study period.
Body weight:
Expected body weight gain was observed in all the animals.
Gross pathology:
No specific gross pathological changes were noted for any of the animals.
Other findings:
Acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute oral toxicity study, the reported LD50 value for test substance, 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane, was > 2000 mg/kg bw.