Dichloromethyl(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane

Endpoint summary

Description of key information

The key acute oral toxicity study, which was conducted according to OECD Test Guideline 423 and in compliance with GLP, the concluded LD50  value was between 200 and 2000 mg/kg bw (LPT, 2002a).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 3rd 2002 to June 10th 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

dose levels differ from guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

dose levels differ from guideline

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Species:

rat

Strain:

other: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, D-97633.
- Age at study initiation: male 41 days, female 48 days.
- Weight at study initiation: male (6 animals) 173-213 g; female (3 animals) 167-178 g.
- Fasting period before study: 16 hours before administration.
- Housing: Makrolon cages (type 3), 2-3 animals per cage. Granulated textured wood (Granulate A2, J. Brandenburg, D49424 Goldenstedt) was used as bedding material.
- Diet ssniff R/M-H V 1530 ad libitum.
- Water: drinking water ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: April 2002 To: June 10th 2002

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: undiluted for highest dose; 10% for second dose level.

MAXIMUM DOSE VOLUME APPLIED: 1.29 ml/kg bw.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: none given in report. The dose used is the limit dose for EU acute oral classification.

Doses:

200, 2000 mg/kg bw

No. of animals per sex per dose:

3 male rats (2000 mg/kg bw); 3 male and 3 female (200 mg/kg bw).

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made before and immediately, at 5, 15, 30 and 60 minutes, then at 3, 6 and 24 hours after administration. All surviving animals were examined at daily intervals. Weights were recorded on days 0, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and macroscopic inspection of all animals that died prematurely; macroscopic examination of all survivors for gross pathological changes was carried out, and microscopic examination of all organs which showed evident lesions would have been performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The three male animals dosed with 2000 mg/kg bw died within 30 minutes. None of the 3 male and 3 female animals dosed with 200 mg/kg bw died.

Clinical signs:

other: 2000 mg/kg bw resulted in the following signs of systemic toxicity; reduced motility, ataxia, reduced muscle tone, dyspnoea. None of the 3 male and 3 female animals dosed with 200 mg/kg bw showed signs of systemic toxicity.

Gross pathology:

No abnormalities were found on macroscopic post mortem examination of the animals.

Other findings:

No effect dose level: 200 mg/kg bw.

Summary of results of acute toxicity study

Symptoms/criteria		2000 mg/kg bw	200 mg/kg bw
		male (n=3)	male (n=3)	female (n=3)
Reduced motility		++ to +++ 5 – 15 minutes	-	-
Ataxia		++ to +++ 5 – 15 minutes	-	-
Reduced muscle tonus		+ to ++ 5 – 15 minutes	-	-
Dyspnoea		++ to +++ 5 – 15 minutes	-	-
Mortality	within 6 hours	3	0	0
	within 14 days	3	0	0
Mean weight	Day 0	204.7 g	181.7 g	173.7 g
	Day 8	-	232.0 g	205.7 g
	Day 15	-	236.0 g	216.7 g
Inhibition of body weight gain		None	None	None
Autopsy findings		None	None	None

+           slight

++          moderate

+++       severe

-            not observed

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Toxicity Category IV by application of Regulation (EC) No 1272/2008

Conclusions:

[2-(Perfluorohexyl)ethyl]dichloro(methyl)silane has been tested for acute oral toxicity in an acute toxic class study conducted according to OECD 423 and in compliance with GLP. All of three male CD rats dosed with 2000 mg/kg bw of test substance died within 6 hours. The clinical signs observed in these animals were reduced motility, ataxia, reduced muscle tone and dyspnoea; there were no gross abnormalities observed on necropsy. There were no clinical signs, deaths or macroscopic abnormalities found in the three male and three female animals treated with 200 mg/kg bw. It was concluded that the LD₅₀ is between 200 and 2000 mg/kg bw. [2-(Perfluorohexyl)ethyl]dichloro(methyl)silane is hydrolytically unstable, with a hydrolysis half-life at 37.5ºC and pH 4 (relevant for conditions in the stomach following oral exposure), of approximately 5 seconds (predicted). Therefore it is considered that the animals would have been exposed to the hydrolysis products, [2-(perfluorohexyl)ethyl]methylsilanediol and hydrochloric acid, and that the effects observed reflect the properties of the hydrolysis products.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

200 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral test data are available for [2-(perfluorohexyl)ethyl]dichloro(methyl)silane, although no testing for this endpoint is required for compliance with REACH as the substance is corrosive. An acute toxicity study was already available for the substance and this is included in the dossier for completeness.

[2-(Perfluorohexyl)ethyl]dichloro(methyl)silane has been tested for acute oral toxicity in an acute toxic class study conducted according to OECD 423 and in compliance with GLP (LPT, 2002a). All of three male CD rats dosed with 2000 mg/kg bw of test substance died within 6 hours. The clinical signs observed in these animals were reduced motility, ataxia, reduced muscle tone and dyspnoea; there were no gross abnormalities observed on necropsy. There were no clinical signs, deaths or macroscopic abnormalities found in the three male and three female animals treated with 200 mg/kg bw. It was concluded that the LD₅₀ is between 200 and 2000 mg/kg bw.

[2-(Perfluorohexyl)ethyl]dichloro(methyl)silane is hydrolytically unstable, with a hydrolysis half-life at 37.5ºC and pH 2 (relevant for conditions in the stomach following oral exposure), of approximately 5 seconds (predicted). Therefore it is considered that the animals would have been exposed to the hydrolysis products, [2-(perfluorohexyl)ethyl]methylsilanediol and hydrochloric acid, and that the effects observed reflect the properties of the hydrolysis products.

Justification for classification or non-classification

Based on the available data, [2-(perfluorohexyl)ethyl]dichloro(methyl)silane requires a Category 4 classification for acute oral toxicity, H302: 'Harmful if swallowed', according to Regulation (EC) No 1272/2008.