Registration Dossier

Administrative data

Description of key information

Acute toxicity:

Oral (similar to OECD 401, no GLP, RL2), rat: LD50=2.83 ml/kg bw (corresponding to 2802 mg/kg bw) (Carpenter et al., 1974)

Dermal (similar to OECD 402, no GLP, RL2), rabbit: LD50=3.18 ml/kg bw (corresponding to 3014 mg/kg bw)

Inhalation: There are no acute inhalation data. 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 reliable data via the oral and dermal routes are available.

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:
Not stated.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report which meets basic scientific principles.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single oral dose toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, four to five weeks of age and 90 to 120 grams in weight which have been reared in the laboratory own colony and maintained from time of weaning on Rockland rat diet, complete. The dosages were arranged in a logarithmic series differing by a factor of two. Whenever possible, the chemical was administered undiluted. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson using the tables of Weil.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellon Institute of Industrial Research, Pennsylvania, USA.
- Age at study initiation: 4-5 weeks.
- Weight at study initiation: 90-120 g (males)
- Diet : Maintained from time of weaning on Rockland rat diet, complete.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
No details given
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
No data
Statistics:
No data
Sex:
male
Dose descriptor:
LD50
Effect level:
2 802 mg/kg bw
Based on:
test mat.
Mortality:
No data
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data

The LD50 of 2.83 ml/kg bw (2.05 - 3.89 ml/kg bw) was converted using a specific density of 0.99 g/cm³.

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The very limited details given in the secondary source indicate the test substance to be of relatively low toxicity via the oral route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 802 mg/kg bw
Quality of whole database:
The study predates OECD test guidelines and GLP. However, the protocol followed meets basic scientific principles.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. The restrictions were that only 4 animals per dose were used and no analytical purity was reported.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
; 4 animals per dose, analytical purity not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
other: albino (no other details)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellon Institute
- Age at study initiation: 3-5 months
- Weight at study initiation: No data
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: Polyethylene sheeting

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Up to 16 mL/kg
Duration of exposure:
24 hours
Doses:
2, 4, and 16 mL/kg
No. of animals per sex per dose:
2 and 4 mL/kg: Four animals
16 mL/kg: Two animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs, gross pathology
Statistics:
No data
Sex:
male
Dose descriptor:
LD50
Effect level:
3 014 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 920 - <= 5 128
Remarks on result:
other: dose given in ml/kg, converted using a specific density of 0.99 g/ml
Mortality:
No deaths in the 2 mL/kg bw group. In the 4 mL/kg bw group 3/4 animals died and both animals in the 16 mL/kg bw group died. In the highest dose group deaths were within one day of dosing. The three animals that died in the 4 mL/kg bw died on Days 2 and 4 following removal of dressings.
Clinical signs:
Two rabbits in the 4 mL/kg bw group were found prostate one day after dosing.
Body weight:
One of the rabbits in the 2 mL/kg bw group lost weight, all other surviving animals gained weight.
Gross pathology:
Congestion throughout the lungs and the abdominal viscera were observed. The liver and kidneys were mottled.
Other findings:
Erythema of the skin.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In an acute dermal toxicity study conducted using a protocol that was similar to OECD 402, but not in compliance with GLP (reliability score 2) the LD50 for the test substance triethoxy(phenyl)silane (CAS: 780-69-8). was 3.18 mL/kg bw in rabbits (equivalent to 3014 mg/kg bw based on a specific density of 0.99 g/mL).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 014 mg/kg bw
Quality of whole database:
The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.

Additional information

Acute oral toxicity:

In the key study for acute oral toxicity 5 male Carworth-Wistar rats were treated by oral gavage with the test substance (Carpenter et al., 1974; RL2). The LD 50 was found to be 2.83 ml/kg bw (2802 mg/kg bw based on a specific density of 0.99 g/cm³). No details about doses or mortality rates were given.

Acute inhalation toxicity:

No data.

Acute dermal toxicity:

In the key study for acute dermal toxicity 4 male Albino New Zealand rabbits were treated with 3.18 ml/kg bw for 24 h under occlusive conditions (Carpenter et al., 1974; RL2). The LD 50 was found to be 3.18 ml/kg bw (3014 mg/kg bw based on a specific density of 0.99 g/cm³). No details about doses or mortality rates were given.


Justification for classification or non-classification

The available data on acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.