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Administrative data

Description of key information

In the key acute oral toxicity study with (3-chloropropyl)triethoxysilane (CAS 5089-70-3; EC 225-805-6) conducted

according to EPA OPP 81-1 Test Guideline (similar to the now deleted OECD Test Guideline 401) and in compliance with GLP, the LD50 was concluded to be at least 5000 mg/kg bw in male and female rats (WIL Research Laboratories Inc., 1996a).

In the key acute dermal toxicity study with (3-chloropropyl)triethoxysilane, conducted according to EPA OPP81-2 Test Guideline (similar to OECD Test Guideline 402) and in compliance with GLP, the LD50 was concluded to be greater than 2000 mg/kg bw in male and female rats. Transient local effect were reported (WIL Research Laboratories Inc., 1996b).

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:
1995-10-09 to 1995-10-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. Portage, MI
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adult (age not specified)
- Weight at study initiation: 271 to 276 g
- Fasting period before study: yes, 18-20 hours prior to dosing and returned to feed 3-4 hours after dosing
- Housing: individual suspended wire-mesh cages
- Diet : Purina Certified Rodent Chow, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: yes, for a minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21.7-22.2 °C
- Humidity: 22.6-46.7%
- Air changes (per hr): not specified
- Photoperiod: 12 hours light/ 12 hours dark
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.05 mL/kg based on the specific gravity of 0.99 g/mL

Doses:
5000 mg/kg bw

No. of animals per sex per dose:
5 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed approximately 1, 3 and 4 hours after test article administration on study day 0, then twice daily (morning and afternoon) thereafter for 14 days. Individual body weights were obtained on study days -1, 0 (initiation), 7 and 14 days (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, organ weights, histopathology, other: A gross necropsy was performed on all animals euthanized (by carbon dioxide asphyxiation)


Preliminary study:
RANGE-FINDING STUDY: Prior to initiation of the main LD50 study, a range-finding study was conducted in which groups of one male and one female rat were dosed at levels of 500, 1000, 2000, 3500 and 5000 mg/kg bw. There were no deaths during the range-finding study. Based on these results, 5000 mg/kg bw was selected as the first level on the main study. One group of five male and five females rats was administered single doses at a level of 5000 mg/kg bw (5.05 mL/kg).
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
There were no deaths during the study
Clinical signs:
other: All clinical findings were noted on day 0 and/or day 1. Wet and/or dried yellow urogenital and/or ventral abdominal staining was observed for all ten animals. Soft stool was noted for six animals. One male rat had mucoid feces. There were no other clinica
Gross pathology:
There were no necropsy findings
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity with (3-chloropropyl)triethoxysilane (CAS 5089-70-3; EC 225-805-6), conducted according to EPA OPP 81-1 Test Guideline (similar to the now deleted OECD Test Guideline 401) and in compliance with GLP, the LD50 was concluded to be greater than 5000 mg/kg bw in male and female rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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:
supporting study
Study period:
1995-10-09 to 1995-10-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD BR
Remarks:
Albino rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories Portage, MI
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: young adult, age not specified
- Weight at study initiation: 230 to 283 g
- Fasting period before study:
- Housing: Individual suspended mesh-bottom cages
- Diet: Purina Certified Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: yes, 7 days minimum prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature: 21.7-22.2 °C
- Humidity: 22.6-46.7%
- Air changes (per hr): not specified
- Photoperiod: 12 hours light/ 12 hours dark
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin removed from hair on the day prior to dosing
- % coverage: 16-20 % of total body surface
- Type of wrap if used: gauze bandaging secured with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with tepid water
- Time after start of exposure: upon completion of the exposure period (24-hour)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.02 mL/kg based on the specific gravity of 0.99 g/mL


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for clinical signs and mortality at 1, 3, and 4 hours post-dose on day 0 and twice daily (morning and afternoon) thereafter for 14 days. The application sites were examined for erythema, edema and other dermal findings approximately 30-60 minutes after bandage removal and daily after for 13 days. The rats were clipped to facilitate dermal observations on study days 7 and 14. Individual body weights were obtained on study days 0 (initiation), 7 and 14 days (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: A gross necropsy was performed on all animals euthanized (by carbon dioxide asphyxiation)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Sex:
male/female
Dose descriptor:
other: NOAEL for systemic toxicity
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study
Clinical signs:
other: Clinical observations included dried red material around the eye(s) or nose for five rats and wet and/or dried yellow urogenital staining was noted for four rats. One animal had clear ocular discharge. These findings are typically noted in association wit
Gross pathology:
Dark red lungs were present for one female. This finding is common in rats that have been euthanized by carbon dioxide inhalation. There were no other gross necropsy findings for all examined tissues.
Other findings:
The test material induced very slight erythema on one animal. Six rats had desquamation. Erythema completely subsided by day 10. There was no edema or other dermal findings.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study conducted according to EPA OPP81-2 Test Guideline (similar to OECD Test Guideline 402) and in compliance with GLP, the LD50 was concluded to be greater than 2000 mg/kg bw in male and female rats. Transient local effect were reported.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The key study for acute oral toxicity (WIL Research Laboratories Inc., 1996) was selected from five studies of reliability score 1 or 2. The most recent was selected as the key study.

In the key acute oral toxicity study conducted according to EPA OPP 81-1 Test Guideline (similar to the now deleted OECD Test Guideline 401) and in compliance with GLP, a single group of five male and five female fasted albino rats were exposed by oral gavage to (3-chloropropyl)triethoxysilane (CAS 5089-70-3; EC 225-805-6) at a dose level of 5000 mg/kg bw. Prior to initiation of the main LD50, a range-finding study was conducted in which groups of one male and one female rat were dosed at levels of 500, 1000, 2000, 3500 and 5000 mg/kg bw. As there were no deaths, 5000 mg/kg bw was selected as the first level on the main study. There were no deaths, remarkable body weight changes or test material-related gross necropsy findings in the main study. All clinical findings were noted on day 0 and/or 1. Wet and/or dried yellow urogenital and/or ventral abdominal staining was observed for all ten animals. Soft stool was noted for six animals. One male rat had mucoid feces. There were no other clinical findings. All animals appeared normal by day 2. The LD50 of (3-chloropropyl)triethoxysilane was therefore concluded to be greater than 5000 mg/kg bw under the conditions of the study (WIL Research Laboratories Inc., 1996a).

Three other studies concluded that the registered substance (3-chloropropyl)triethoxysilane should not be classified for acute oral toxicity.

In one of the supporting acute oral toxicity studies, conducted according to the now deleted OECD Test Guideline 401 and in compliance with GLP, (3-chloropropyl)triethoxysilane was administered by oral gavage to ten Fisher 344 male and female rats (5 per sex) at a single dose of 2000 mg/kg bw. No animals died during the course of the study. The clinical signs noted during the study period were soft stool and anogenital staining. No apparent effect on body weight gains were noted during the 14-day observation period. No macroscopic findings were noted at the time of necropsy. The LD50 was concluded to be at least 2000 mg/kg bw in male and female rats (Dow Corning Corporation, 1995).

In the two other supporting acute oral toxicity studies, conducted according to a protocol comparable to OECD Test Guideline 401 and prior to the adoption of GLP, the LD50 values for (3-chloropropyl)triethoxysilane were concluded to be greater than 5 mL/kg bw (Consultox Laboratories, 1976) and equal to 14.1 mL/kg bw in male and female Wistar rats (TNO-CIVO 1980).

The fifth study was limited in respect of the amount of experimental detail available and the test laboratory was not identified in the report. The study was conducted according to a protocol which appears to be similar to the now deleted OECD Test Guideline 401, and an LD50 of 1297 mg/kg bw was reported (Unknown, 1975). However, since the gross pathology findings (ulcers in stomach and intestines) were specific to that study only, and since four more recent studies clearly show LD50 values in excess of 2000 mg/kg bw, this result has not been used for classification.

The key acute dermal toxicity study was selected from three reliability 1 guideline studies, all in compliance with GLP and OECD Test Guideline 402 or similar. All studies gave LD50 values greater than 2000 mg/kg bw for rats or rabbits, the key was selected as being the most recent study.

In the key acute dermal toxicity study conducted according to EPA OPP 81-2 Test Guideline (similar to OECD Test Guideline 402) and in compliance with GLP, (3-chloropropyl)triethoxysilane was administered once dermally at a dose of 2000 mg/kg bw to the clipped, intact skin of five male and five female albino rats for 24 -hour exposure period under semi-occlusive dressing. There were no deaths or test material-related findings, body weights changes or gross necropsy findings. The test material induced very slight erythema in one animal. Six rats had desquamation. Erythema completely subsided by day 10. There was no edema or other dermal findings. The LD50 was concluded to be greater than 2000 mg/kg bw in male and female rats (WIL Research Laboratories Inc., 1996b).

In a supporting acute dermal toxicity study conducted according to OECD Test Guideline 402 and in compliance with GLP, (3-chloropropyl)triethoxysilane was administered once dermally at a dose of 2000 mg/kg bw to the intact skin of ten rabbits (5 per sex) under an occlusive dressing for a period of 24 hours. No animals died during the course of the study. No significant clinical signs and no apparent effect on body weight were noted during the 14-day observation period. No macroscopic findings were noted at the time of necropsy. On the basis of the data presented in this report, the LD50 was concluded be greater than 2000 mg/kg bw in male and female New Zealand White rabbits (Dow Corning Corporation, 1995b).

In the other supporting acute dermal toxicity with (3-chloropropyl)triethoxysilane, conducted according to OECD Test Guideline 402 and in compliance with GLP, the LD50 was concluded to be greater than 2000 mg/kg bw in male and female rats. There were no mortalities during the 14-day study period. Slight erythema was evident in one female and two male animals at 48 hours which was completely reversible by the 6th day. Weight gain during the study period was within normal limits. Macroscopic examination showed no organ specific test substance related effects (Hüls AG, 1993).

Justification for classification or non-classification

Based on the available data for the oral and dermal routes, (3-chloropropyl)triethoxysilane is not classified for acute toxicity according to Regulation (EC) No 1272/2008. No data are available for the inhalation route.