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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
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 for the structural analogue substance triethoxy(phenyl)silane (CAS: 780-69-8).The restrictions were that only 4 animals per dose were used and no analytical purity was reported.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VIII.
Author:
Carpenter CP; Weil CS; Smyth HF Jr
Year:
1974
Bibliographic source:
Toxicology and Applied Pharmacology 28(2): 313-9.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxy(phenyl)silane
EC Number:
212-305-8
EC Name:
Triethoxy(phenyl)silane
Cas Number:
780-69-8
Molecular formula:
C12H20O3Si
IUPAC Name:
Triethoxy(phenyl)silane

Test animals

Species:
rabbit
Strain:
other: albino (no other details)
Sex:
male
Details on test animals or test system 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

Administration / exposure

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

Results and discussion

Effect levels
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 in the 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:
other: Two rabbits in the 4 mL/kg bw group were found prostate one day after dosing.
Gross pathology:
Congestion throughout the lungs and the abdominal viscera were observed. The liver and kidneys were mottled.
Other findings:
Erythema of the skin.

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 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 structural analogue 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).