Dichlorocyclohexylmethylsilane

Endpoint summary

Description of key information

The key acute oral study (LPT, 2003), conducted with the registered substance, according to OECD TG 423 and in compliance with GLP, reported an LD₅₀ in male and female rats greater than 2000 mg/kg bw when dosed in corn oil. No treatment-related effects were reported.

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.

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.

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:

2002-03-13 to 2002-07-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

There were minor deviations from the guideline with respect to selection of doses.

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

doses of 2000 and 200 mg/kg bw used, the guideline (2001) recommends 2000 followed by 300 mg/kg bw.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

other: Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, GERMANY
- Age at study initiation: 42 d (m). 53 d (f)
- Weight at study initiation: 160-169 g (m), 168-176 (f)
- Fasting period before study: not stated
- Housing: 2-3/Makrolon type III cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES:unclear

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: presumably 200 mg/ml
- Justification for choice of vehicle: 'to buffer off the irritating effect'
- Lot/batch no. (if required): 81K2204

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 5, 15, 30 and 60 minutes, 3, 6 and 24 h, then at least daily until day 14; body weights weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology on organs showing lesions

Statistics:

None

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

none

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity study, conducted according to OECD TG 423 and in compliance with GLP, identified an acute oral LD50 value greater than 2000 mg/kg bw in male and female rats. There was no evidence of toxicity at the tested dose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 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

The key acute oral study (LPT, 2003), conducted with the registered substance, according to OECD TG 423 and in compliance with GLP, reported an LD₅₀in male and female rats greater than 2000 mg/kg bw when dosed in corn oil. No treatment-related effects were reported. No histopathology was conducted on any tissues.

Justification for classification or non-classification

On the basis of the available measured LD₅₀ value, dichloro(cyclohexyl)methylsilane is not classified for acute toxicity according to Regulation (EC) No 1272/2008.