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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-04-24 to 2007-05-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD test under GLP
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. QA statement)
Test type:
other:
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
480-370-1
EC Name:
-
Cas Number:
21743-27-1
Molecular formula:
Hill formula: C11H25NO4Si CAS formula: C11H25NO4Si
IUPAC Name:
4-[(triethoxysilyl)methyl]morpholine

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: male: 220 - 234 g, female: 190 - 213 g
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approx. 10 % of the total body surface


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using tap water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight




Duration of exposure:
24 h
Doses:
2000 mg/kg bw (Limit test) for each sex
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: a clinical examination was made at least twice a day on the day of dosing and once a day thereafter
- Weighing on day: 0, 7 and 14
- Necropsy of survivors performed: gross necropsy.
Statistics:
not applicable

Results and discussion

Preliminary study:
not apllicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: None
Mortality:
No mortality has been observed.
Clinical signs:
other: No clinical signs have been observed.
Gross pathology:
No changes were found in any animal.
Other findings:
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was determined to be > 2000 mg/kg bw.
Executive summary:

An acute dermal toxicity test according to OECD 423 was performed. The test item was administered topically at a single dose (2000 mg/kg bw) by applying uniformly over an area which was approx. 10% of the total body surface. 5 male animals (HsdRccHan:WIST rats) as well as 5 female animals (HsdRccHan:WIST rats) were used. The test item was held in cointact by an occlusive dressing with the skin throughout a 24 -hour period. No mortality occured during the study. No clinical signs of toxicity were observed throughout the observation period. The body weight gain of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. Therefore, the LD50 (dermal, rat) was determined to be > 2000 mg/kg bw.