Registration Dossier

Administrative data

Description of key information

In an acute toxic class study conducted to OECD 423 and to GLP (LPT, 2002a) the acute oral LD50 of 3-chloropropyl(dimethoxy)methylsilane was in the range 200-2000 mg/kg bw in rats.

There are no acute dermal toxicity data for 3-chloropropyl(dimethoxy)methylsilane. Therefore data have been read across from the structurally-related 3-chloropropyl(diethoxy)methylsilane. In an acute dermal limit study (Hüls AG, 1997b) conducted to OECD 402 and GLP, the dermal acute LD50 for the related substance, 3-chloropropyl(diethoxy)methylsilane, was greater than 2000 mg/kg bw in Wistar rats.

There are no acute inhalation studies on 3-chloropropyl(dimethoxy)methylsilane or the analogue substances.

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:
04.03.2002 to 13.08.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: CD/Crl:CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: Males: 41 days; Females: 48 days
- Weight at study initiation: Males: 206-224 g; Females: 172-197 g
- Fasting period before study: 16 hours before treatment
- Housing: Type III Makrolon cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


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

IN-LIFE DATES: From: 09.04.2002 To: 02.05.2002
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: Not stated, but assumed to be low toxicity
- Lot/batch no. (if required): No data
- Purity: No data


MAXIMUM DOSE VOLUME APPLIED: 1.96 ml/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit dose
Doses:
200 and 2000 mg/kg bw
No. of animals per sex per dose:
Three
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: before and immediately, at 5, 15, 30 and 60 minutes, as well as at 3, 6 and 24 hours after administration. Weight: before and then weekly after administration
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination.
Statistics:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 200 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw resulted in one male and two female deaths. No deaths at 200 mg/kg bw
Clinical signs:
All animals of both sexes showed slight to moderately reduced motility, slight to moderate ataxia, slight to moderately reduced muscle tone and slight to moderate dyspnoea from 15 minutes up to 24 hours after administration at 2000 mg/kg bw.
There were no signs of toxicity at 200 mg/kg bw.
Body weight:
There were no effects on body weight gain.
Gross pathology:
No abnormalities were found.
Other findings:
No other findings.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In an acute toxic class study conducted to OECD 423 and to GLP (reliability score 1) the acute oral LD50 for 3-chloropropyl(dimethoxy)methylsilane was in the range 200-2000 mg/kg bw in rats. All animals of both sexes showed slight to moderately reduced motility, slight to moderate ataxia, slight to moderately reduced muscle tone and slight to moderate dyspnoea from 15 minutes up to 24 hours after administration at 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
200 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07.10.1996 to 24.10.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: 200-300 g (variation did not exceed ±20% of mean body weight)
- Fasting period before study: No data
- Housing: Individually in Makrolon type II cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days


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

IN-LIFE DATES: From: 07.10.1996 To: 24.10.1996
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsolumbar
- % coverage: 10 % of body surface clipped
- Type of wrap if used: Semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with corn oil
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.03 cm3/kg bw



Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were checked at least daily for mortalities, they were observed for clinical signs soon after dosing and at regular intervals for the remainder of Day 0 (day of dosing), then daily until the end of the 14 day observation period. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examinations.
Statistics:
None done
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no clinical signs.
Body weight:
One female rat showed a slight body weight loss on Day 7. The other four female rats showed no change in body weight gain. All female rats showed minimal body weight gain by the end of the study. The variation in body weights was not thought to be treatment-related.
Gross pathology:
No findings.
Other findings:
There were no other findings.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal limit study (reliability score 1) conducted to OECD 402 and GLP, the dermal acute LD50 for 3-chloropropyl(diethoxy)methylsilane was greater than 2000 mg/kg bw in Wistar rats. There were no significant clinical effects.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

In an acute toxic class study conducted to OECD 423 and to GLP (LPT, 2002a) the acute oral LD50 of 3-chloropropyl(dimethoxy)methylsilane was in the range 200-2000 mg/kg bw in rats. All animals of both sexes showed slight to moderately reduced motility, slight to moderate ataxia, slight to moderately reduced muscle tone and slight to moderate dyspnoea from 15 minutes up to 24 hours after administration at 2000 mg/kg bw.  

Acute oral toxicity studies on the analogue substances, 3-chloropropyl(trimethoxy)silane (Evonik Degussa, 1993), 3-chloropropyl(triethoxy)silane (DCC, 1995) and 3-chloropropyl(diethoxy)methylsilane (Hüls AG, 1997), are included in support of the read-across for other endpoints. An acute oral toxicity test on chloromethyl(triethoxy)silane (Harlan, 2012) is included in support of the read-across justification discussion on bias in selection of analogue group substances.

There are no acute dermal toxicity data for 3-chloropropyl(dimethoxy)methylsilane. Therefore data have been read across from the structurally-related 3-chloropropyl(diethoxy)methylsilane. In an acute dermal limit study (Hüls AG, 1997b) conducted to OECD 402 and GLP, the dermal acute LD50 for the related substance, 3-chloropropyl(diethoxy)methylsilane, was greater than 2000 mg/kg bw in Wistar rats. There were no significant clinical effects.

Acute dermal toxicity studies on the analogue substances, 3-chloropropyl(trimethoxy)silane (Evonik Degussa, 1993) and 3-chloropropyl(triethoxy)silane (DCC, 1995), are included in support of the read-across for the analogue group.

There are no acute inhalation studies on 3-chloropropyl(dimethoxy)methylsilane or the analogue substances.

See Section 13 of IUCLID for the read-across justification reports.

.

Justification for classification or non-classification

Based on the available acute toxicity data, 3-chloropropyl(dimethoxy)methylsilane is classified 'Acute Toxic 4 (oral)' with the hazard statements 'H302: Harmful if swallowed and according to Regulation (EC) No 1272/2008.