Dichloromethyl(3,3,3-trifluoropropyl)silane

Endpoint summary

Description of key information

Oral (OECD TG 423): LD 50 = 200- 2000 mg/kg bw (male/female)
Inhalation: No data available  (waiving according to Column 2 of REACH Annex VIII (Section 8.5.3))
Dermal: No reliable data available (waiving according to Column 2 of REACH Annex VIII (Section 8.5.2))

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Quality of whole database:

The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

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

Dichloromethyl(3,3,3 -trifluoropropyl)silane hydrolyses very rapidly (half-life 12 seconds) in contact with water and moist air releasing two moles of hydrogen chloride (HCl) for one mole of parent material. It is therefore classified as corrosive and acute toxicity testing is not appropriate.

Acute Oral:

In the key acute oral toxicity study (LPT, 2002) conducted in compliance with OECD 423 (adopted in 1996), and in accordance with GLP, the test material was administered to Crl:CD rats via gavage. 2000 mg/kg bw resulted in the death of 2 /3 males within 4 days. No signs of systemic toxicity were noted at this dose level. 200 mg/kg bw resulted in the death of 1/3 males and 1/3 females within 4 days. No signs of systemic toxicity were noted at 200 mg/kg bw. The authors concluded a LD50 range of 200 -2000 mg/kg bw. However, based on the interpretation flowchart of the OECD guideline followed, the LD50 cut-off value was set at 1000 mg/kg bw.

In a supporting acute oral toxicity study (TNO, 1998) conducted in compliance with OECD 423 (adopted in 1996), and in accordance with GLP, the oral LD50 of dichloromethyl (3,3,3-trifluoropropyl)silane is considered to be between 200 and 2000 mg/kg bw, in both males and females. There is a further limited report (RL 4) of an acute oral study (DCC, 1967) equivalent or similar to the now deleted OECD 401 and which predates GLP, which identified an oral LD50 value in male mice of <1.00 ml/ kg bw. Based on a relative density of 1.25 g/ml, the LD50 (oral) is <1250 mg/kg bw.

Acute Dermal:

No reliable data are available to assess the acute dermal potential of dichloromethyl (3,3,3-trifluoropropyl)silane, however, in accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the dermal route (required in Section 8.5.3) does not need to be conducted as the substance is classified as corrosive. A reliability 4, limited report of a generally well conducted study that predates GLP, identified a estimated dermal LD50 value of 2.00 ml/kg bw for dichloromethyl (3,3,3-trifluoropropyl)silane in two albino rabbits. Severe skin irritation characterised by sloughing of skin, bleeding, fissures and serious oozing was observed in both animals.

Acute Inhalation.

No data are available to assess the acute inhalation potential of dichloromethyl (3,3,3-trifluoropropyl)silane, however, in accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as the substance is classified as corrosive.

Justification for selection of acute toxicity – oral endpoint
The key study was selected for assessment.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as the substance is classified as corrosive.

Justification for selection of acute toxicity – dermal endpoint
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the dermal route (required in Section 8.5.3) does not need to be conducted as the substance is classified as corrosive. However, a supporting study with limited documentation (only an abstract was available for review) indicates that mortality occurred as a result of severe local skin damage rather than systemic toxicity, and hence, classification for acute dermal toxicity is not warranted.

Justification for classification or non-classification

Based on the available key study for acute oral toxicity, dichloromethyl(3,3,3 -trifluoropropyl)silane needs to be classified as

R22 "Harmful if swallowed" according to the criteria of EU Directive 67/548/EEC, and Acute Toxic 4 (oral) under Regulation (EC) 1272/2008.