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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Version / remarks:
(as stated in SIAR, 2003, not evident from study report seen by this reviewer)
GLP compliance:
not specified
Remarks:
SIAR (2003) notes that this laboratory was certified at the date of this study
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropyltriethoxysilane
EC Number:
213-048-4
EC Name:
3-aminopropyltriethoxysilane
Cas Number:
919-30-2
Molecular formula:
C9H23NO3Si
IUPAC Name:
silane

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no details given
- Age at study initiation: no details given
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight
- Housing: no details given
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: no details given

ENVIRONMENTAL CONDITIONS
no details given

IN-LIFE DATES: no details given

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
n/a

MAXIMUM DOSE VOLUME APPLIED: 4 ml/kg bw
Doses:
4, 2, and 1 ml/kg bw in males; 2, 1.41 and 1 ml/kg bw in females
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology (kidney and urinary bladder of: 2 males at 4 ml/kg bw; 2 males and 3 females at 2 ml/kg bw.
Statistics:
Moving Average Method (Thompson, 1974; Weil, 1983)

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2.83 mL/kg bw
95% CL:
> 1.61 - < 4.98
Remarks on result:
other: Equivalent to 2690 mg/kg bw
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1.57 mL/kg bw
95% CL:
> 1.34 - < 1.85
Remarks on result:
other: Equivalent to 1490 mg/kg bw
Mortality:
Deaths at 1.41 and 2 ml/kg bw in females and at 4 and 2 ml/kg bw in males. No deaths in either sex at 1 ml/kg bw. See table 1.
Clinical signs:
other: See table 1
Gross pathology:
See table 2
Other findings:
- Histopathology: examination of the kidneys and urinary bladders of a selected group revealed tubular necrosis in those that died and some evidence of lesser kidney damage in those that survived (see table 2).
- Potential target organs: kidney

Any other information on results incl. tables

Table 1: Number of animals that died, time range for mortality, body weight change and overt toxicity

 Dose
(ml/kg bw)

Mortality (dead/total)

Time range of deaths (days)

Mean body weights (days 0/7/14) (g)

Overt toxicity

Male

Female

Combined

Male

Female

Male

Female

1.00

0/5

0/5

0/10

-

238/278/304

211/231/241

None.

Sluggishness, recovery at 2 days.

1.41

-

1/5

-

1

-

212/227/234

-

Sluggishness, periurogenital staining (positive for blood), red encrusted fur around nose; survivors recovered at 2 days.

2.00

1/5

5/5

6/10

2-4

234/251/302

223/-/-

Sluggishness, unkempt appearance, periurogenital brown staining, red encrusted fur around nose and eyes, closed eyelids, emaciation and diarrhoea. Survivors recovered at 5 to 9 days.

Sluggishness, lacrimation, unkempt appearance, red encrusted fur around nose and eyes and diarrhoea.

4.00

4/5

-

-

1-2

244/254/283

-

Sluggishness, lacrimation, kyphosis (curvature of the thoracic spine), piloerection and red encrusted fur around nose. Survivor recovered at 3 days.

-

 

Table 2: Gross and microscopic examinations

 Dose
(ml/kg bw)

Gross examination

Microscopic examination of kidneys and urinary bladder

Male

Female

Male

Female

1.00

Nothing remarkable.

Nothing remarkable.

-

-

1.41

-

Victim: lungs dark red; stomach (glandular) white to dark red; intestine filled with yellow liquid.

Survivors: nothing remarkable.

-

-

2.00

Victim: bright red lungs; dark red (glandular) stomachs filled with light brown liquid.

Survivors: nothing remarkable.

Victims: lungs bright pink; stomachs (glandular) dark red or mottled; stomachs and intestines filled with light brown liquid; intestines of one yellow; kidneys dark red.

Examined 2 survivors: moderate renal tubular hyperplasia (indicative of prior necrosis) and mild tubular mineralization in 1; no urinary bladder lesions

Examined 3 victims: moderate tubular necrosis; mild to moderate tubular mineralization; moderate kidney congestion; no urinary bladder lesions

4.00

Victims: dark red, mottled lungs; dark red (glandular) stomachs; stomachs and intestines filled with yellow liquid; spleen mottled, dark red.

Survivor: nothing remarkable.

-

Examined 2 victims: moderate tubular necrosis; marked kidney congestion; epithelial necrosis in the urinary bladder (only 1 rat examined).

-

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Based on LD50 value for male rats.
Conclusions:
A reliable study conducted very largely in compliance with a standard guideline and probably in accordance with GLP, identified LD50 values of 1.57 and 2.83 ml/kg bw in female and male rats, respectively.

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