Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-05-13 to 1997-05-27
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
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:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, 33176 Borchen, Germany
- Age at study initiation: no information
- Weight at study initiation: 200-300 g
- Fasting period before study: no
- Housing: Makrolon type III cages, one animal per cage, soft wood bedding
- Diet: Ssniff R 10 diet in pellet form ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 =/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: To: 27.05.1997

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 x 50 mm
- % coverage: no information.
- Type of wrap if used: semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure the treated area of skin was cleansed with corn oil and absorbent paper.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Undiluted test substance was applied to skin prepared by clipping approximately 24 hours before exposure.
- Amount(s) applied (volume or weight with unit): 1.50 cm²/kg bw.

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
five males and five females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for clinical signs approximately 30 minutes after dosing and at hourly intervals for the remainder of day one, then daily. The rats were checked at least twice daily for any mortalities. The dermal response was observed daily for irritation and lesions. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs; body weight; macroscopic appearance of tissues in abdominal and thoracic cavities.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: There were no mortalities
Mortality:
There were no mortalities in any of the five male and five female rats treated dermally with 2000 mg/kg bw of test substance.
Clinical signs:
There were no signs of systemic reaction to treatment. No local dermal irritations at the treatment site were observed following removal of the dressings.
Body weight:
Two female rats showed a minimal bodyweight loss on day 7. At the end of the study a minimal body weight gain was recorded in all animals which was considered a physiological finding and not substance related.
Gross pathology:
No abnormalities were observed on examination at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
[2-(perfluorohexyl)ethyl]triethoxysilane has been tested for acute dermal toxicity to rats in a study conducted according to OECD TG 402 and in compliance with GLP. No mortalities or clinical signs were observed in any of the five male and five female animals exposed for 24 hours to 2000 mg/kg bw of undiluted test substance, either during exposure or in the following 14 day observation period. It is concluded that the LD50 is ˃2000 mg/kg bw.