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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
Study period:
14.09.1998 to 09.02.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dow Corning Z-6020 Silane
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 7-12 weeks
- Weight at study initiation: 202-286 g
- Fasting period before study: Yes, overnight
- Housing: Individually, in suspended metal cages with mesh floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): Minimum of 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 24.09.1998 To: 25.11.1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 4.954 mL/kg
Doses:
500, 1200 (initially only two males and two females were treated on humane grounds to ensure the dose level selected did not result in greater than 50% mortality), 1200, 3000 and 5000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed daily for mortality and morbidity. The bodyweight of each rat was recorded on Days 1 (prior to dosing, 8 and 15 (or at death). Clinical signs were observed immediately after dosing and at approximately hourly intervals for the remainder of Day 1. On subsequent days animals were observed twice daily.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination
Statistics:
The acute median lethal dose was calculated using the method of Finney.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 295 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 539 - <= 3 423
Sex:
female
Dose descriptor:
LD50
Effect level:
1 897 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 077 - <= 3 343
Sex:
male
Dose descriptor:
LD50
Effect level:
2 574 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 931 - <= 3 431
Mortality:
Four males and all five females treated with 3000 mg/kg bw and all of those at 5000 mg/kg bw died during the study. Deaths occurred between 2 hours and Day 2. There were no deaths in the other groups.
Clinical signs:
Piloerection (all doses), hunched posture, waddling/unsteady gait, pallid extremities, eyes dulled, increased salivation, abnormal respiration, ungroomed appearance, fecal disturbances, increased sensitivity and increased lacrimation (among rats at 1200, 3000 and/or 5000 mg/kg bw), walking on toes, blue/cold extremities, lethargy, partially closed eyelids and body tremors (3000 and 5000 mg/kg bw) and prostration (5000 mg/kg bw). These clinical signs had resolved by Day 6.
Body weight:
No significant effect.
Gross pathology:
All animals that died had congestive changes in the majority of organs and tissues. There were no changes in animals that survived to the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
Conclusions:
In an acute oral toxicity study conducted to EPA OPPTS 870.1100 (Acute Oral Toxicity) and to GLP (reliability score 1) the LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine was 2295 mg/kg bw in rats. Piloerection (all doses), hunched posture, waddling/unsteady gait, pallid extremities, eyes dulled, increased salivation, abnormal respiration, ungroomed appearance, fecal disturbances, increased sensitivity and increased lacrimation (among rats at 1200, 3000 and/or 5000 mg/kg bw), walking on toes, blue/cold extremities, lethargy, partially closed eyelids and body tremors (3000 and 5000 mg/kg bw) and prostration (5000 mg/kg bw). These clinical signs had resolved by Day 6. All animals that died had congestive changes in the majority of organs and tissues. There were no changes in animals that survived to the end of the observation period.