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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:
1990-01-13 to 1995-03-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloropropyl)triethoxysilane
EC Number:
225-805-6
EC Name:
(3-chloropropyl)triethoxysilane
Cas Number:
5089-70-3
Molecular formula:
C9H21ClO3Si
IUPAC Name:
(3-chloropropyl)triethoxysilane

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan
- Age at study initiation: ca. 4 months
- Weight at study initiation: 2593-2918g males, 2561-2793g females
- Fasting period before study: not reported
- Housing: The animals were housed in individual hanging stainless steel wire mesh cages in an animal room.
- Diet: Up to 125g/day Certified Rabbit Chow ~5322, Purina Mills, Inc. St. Louis, Missouri
- Water: ad libitum
- Acclimation period: 25 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 67-68 (19.4-20°C)
- Humidity: 54 %
- Photoperiod: 12 hours dark/ 12 hours light

IN-LIFE DATES: From: 30/12/1994 To: 07/02/1995

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: dorsal skin removed from hair
- % coverage: 15% of the body surface
- Type of wrap if used: The test site and torso was then wrapped with 8 ply gauze bandaging, occluded with plastic wrap and secured with 3" Dermiform tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The test site was washed with water and dried with disposable towels.
- Time after start of exposure: approximately 24 hours.


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.0163 ml/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 per sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed approximately 1, 2 and 4 hours after test article administration on study day 1, then twice daily (morning and afternoon) for 13 additional days (once on the day of the necropsy). Individual body weights were obtained immediately prior to test article administration, on study day 8 and at study termination (day 15).
- 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 intravenous sodium pentobarbital overdose) at study termination (day 15); no tissues were saved.
Statistics:
No statistical analysis was reported.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No deaths occurred during the 14-day study period.
Clinical signs:
other: Desquamation of the test site was noted in four animals. Additionally, a small red raised area on the test site was noted in a single animal. These signs are considered to be due to either the test article and/or treatment.
Gross pathology:
No macroscopic findings were noted at the time of necropsy. The antemortem observations were not confirmed at the time of necropsy.
Other findings:
- Potential target organs: None identified.
- Other observations: No sex specific differences reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study 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 New Zealand White rabbits.