Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-05-12 to 1997-05-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wistar rats (HsdCpb:WU / SPF) from Harlan Winkelmann GmbH, Gartenstraβe 27, 33176 Borchen.
- Age at study initiation: young adult animals
- Weight at study initiation: weight variation did not exceed ±20% of the mean body weight
- Fasting period before study: about 16 hours
- Housing: groups of max. five rats in Makrolon type III cages, sexes separated
- Diet (e.g. ad libitum): Ssniff R diet in pellet form (laboratory standard rat diet) ad libitum; ad libitum 3 hours after application
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no information in report
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
In the first instance 3 male rats were given a single oral application of the test substance at a dose level of 2000 mg/kg bw. Since no mortalities occurred within 24 hours p.a., 3 female rats were treated in the same way
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed soon after dosing and at frequent intervals for the remainder of day 0 (a period of approximately 6 hours). On subsequent days animals were observed once a day. That nature and severity of the clinical signs were recorded at each observation. Individual body weights were recorded on days 0 (prior to dosing), 7 & 14
- Necropsy of survivors performed: animals were killed on day 14 by CO2 inhalation and subjected to a macroscopic examination after opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded for each animal
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No rats died following a single oral application at 2000 mg/kg bw.
Clinical signs:
There were no deaths and no signs of systemic reaction to treatment.
Body weight:
All animals achieved satisfactory body weight gains throughout the study.
Gross pathology:
No abnormalities.
Other findings:
Macroscopic examination: No macroscopic findings.

Any other information on results incl. tables

Acute oral toxicity study: body weights

Dose

Body weight (g) on day

Body weight gains (g)

Body weight (g) on day

Body weight gains (g)

Animal Number

Substance

mg/kg bw

0

7

14

Week 1

Week 2

0

7

14

Week 1

Week 2

males

females

1

2000

148

210

248

62

38

134

160

169

26

9

2

2000

155

214

252

59

38

144

175

192

31

17

3

2000

152

204

246

52

42

136

161

161

25

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
[2-(Perfluorohexyl)ethyl]triethoxysilane 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 a group of 3 male and 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.