Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Qualifier:
according to
Guideline:
other: EC 440/2008
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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, 94633 Sulzfield, Germany
- Age at study initiation: 9-11 weeks
- Weight at study initiation: animals 1-3: 155-166 g; animals 4-6: 139-142 g
- Fasting period before study: 16-19 hours prior to administration
- Housing: Groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 02102140831)
- Diet: Altromin 1324 maintenance diet for rats and mice (lot no. 1239) ad libitum
- Water: tap water ad libitum, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days under laboratory conditions

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 per step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighed on day 1 (prior to administration), day 8 and day 15; clinical examination made several times on the day of dosing (at least once during the first 30 minutes, and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed once daily until the end of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: morbidity, mortality, changes in the skin, fur, eyes and mucous membranes, changes in respiratory system, circulatory system, autonomic system and CNS. Particular attention directed to observation of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Statistics:
None described in report.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities.
Clinical signs:
No specific signs.
Body weight:
None of the animals showed weight loss during the observation period, and the body weight gains were within the normal range of variation for the strain.
Gross pathology:
No specific gross pathological changes were recorded for any animal.

Any other information on results incl. tables

Acute oral toxicity: absolute body weights and body weight gain

Step

Animal No.

Starting Dose (mg/kg bw)

Body weight (g)

Body weight in comparison to day 1 (%)

Day 1

Day 8

Day 15

1

1

2000

166

196

193

16

2

155

171

177

14

3

166

190

198

19

2

4

2000

139

154

170

22

5

142

158

172

21

6

141

162

173

23

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
[2-(perfluorohexyl)ethyl]trimethoxysilane has been tested in an acute oral toxicity study conducted according to OECD 423 and in compliance with GLP. The undiluted test substance was administered by gavage to two groups, each of 3 female rats. The rats were dosed at 2000 mg/kg bw. There were no deaths and no signs of systemic reaction to treatment. All animals achieved satisfactory bodyweight gains throughout the study. The LD₅₀ was determined to be >2000 mg/kg bw.