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Diss Factsheets

Administrative data

Description of key information

Oral (OECD 401), rat: LD50 > 5002 mg/kg bw
Inhalation: No data available
Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw

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:
11 Nov - 25 Nov 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1983)
Deviations:
yes
Remarks:
No data for analytical purity is available.
Qualifier:
according to guideline
Guideline:
other: EEC (84/449/EWG) (1984)
Deviations:
yes
Remarks:
No data for analytical purity is available.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Wistar Bor: WISW (SPFTNO)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., Borchen, Germany
- Age at study initiation: 49 days (males), 63 days (females)
- Weight at study initiation: 138 – 148 g (males), 132 – 137 g (females)
- Housing: animals were caged individually in Macrolon cages (type II)
- Bedding: softwood granulate type I, coarse I (Bogner GmbH, Solingen, Germany)
- Diet: standard diet, ssniff (R) Special diet for rats (ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Fasting period before study: 16 h before treatment
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 – 22.5
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.62 ml/kg bw

Doses:
5002 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 6 – 8 h after dosing and subsequently once daily thereafter
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: External appearance, body orifices, body cavities (thoracic and abdominal) and their contents were examined macroscopically.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 002 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality observed throughout the study period.
Clinical signs:
The test substance did not produce systemic toxic effects.
Body weight:
All animals showed the expected body weight gains over the study period.
Gross pathology:
No abnormalities were detected at necropsy at the end of the 14-day observation period.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test material was investigated for acute oral toxicity according to the OECD TG 401, and in compliance with GLP. The test material was administered once via oral gavage to 5 Wistar rats per sex at a limit dose of 5002 mg/kg bw. No mortality and no clinical signs occurred throughout the study period. Based on these findings, classification for acute oral toxicity according to Regulation (EC) No 1272/2008 is not warranted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 002 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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
Study period:
10 Feb - 24 Feb 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. No data for analytical purity is reported. OECD TG 402: “A limit test at one dose level of at least 2000 mg/kg bodyweight may be carried out in a group of 5 male and 5 female animals.” Only 3 animals of each sex were treated with the test material in the present study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1981
Deviations:
yes
Remarks:
No data for analytical purity is reported. OECD TG 402: “A limit test at one dose level of at least 2000 mg/kg bodyweight may be carried out in a group of 5 male and 5 female animals.” Only 3 animals of each sex were used in the present study.
Qualifier:
according to guideline
Guideline:
other: EG 84/449/EWG
Version / remarks:
1984
Deviations:
yes
Remarks:
No data for analytical purity is reported. OECD TG 402: “A limit test at one dose level of at least 2000 mg/kg bodyweight may be carried out in a group of 5 male and 5 female animals.” Only 3 animals of each sex were used in the present study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
other: White Russian
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 3 – 4 months (males), 4 months (females)
- Weight at study initiation: 2140 – 2310 g (males), 2060 – 2260 g (females)
- Housing: animals were caged individually in stainless-steel cages
- Diet: maintenance diet for rabbits (ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Fasting period before study: at the day of application with the test substance
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: shorn skin of the region between shoulder blade and sacrum
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and occluded with a piece of bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated skin was rinsed with water to remove any residual test item.
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 6 – 8 h after dosing and subsequently once daily thereafter
- Frequency of weighing: prior to dosing and 7 and 14 days after treatment
- Necropsy of survivors performed: yes
- Other examinations performed: external appearance, body orifices, body cavities (thoracic and abdominal) and their contents were examined macroscopically
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality observed throughout the study period.
Clinical signs:
The test substance did not produce systemic toxic effects. The treated skin showed redness after removal of the test substance. Skin scales were observed between day 3 and day 7 post-application with the test substance, which were fully reversible within 13 days post-application.
Body weight:
All animals showed the expected body weight gains over the study period.
Gross pathology:
No abnormalities were detected at necropsy at the end of the 14-day observation period.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no mortality occurred and no clinical signs of toxicity were observed. Skin scales were observed between day 3 and day 7 post-application with the test substance, which were fully reversible within 13 days post-application. Therefore, the test substance does not need to be classified for acute dermal toxicity according to Regulation (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Acute toxicity: oral

An acute oral toxicity study performed according to OECD 401 and in compliance with GLP with Trimethoxyoctadecylsilane (CAS 3069-42-9) is available (Asta-Werke, 1986). In this limit test five fasted Wistar rats of each sex were administered one dose of 5002 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days post-administration. No signs of clinical toxicity were reported, no mortalities occurred during the observation period. All animals showed the expected body weight gains over the study period. No abnormalities were detected at necropsy at the end of the 14-day observation period. Thus, the acute oral LD50 value for males/females was considered to be greater than 5002 mg/kg bw.

 

Acute toxicity: inhalation

No data on acute inhalation toxicity is available.

 

Acute toxicity: dermal

An acute dermal toxicity study performed according to OECD 402 and in compliance with GLP with Trimethoxyoctadecylsilane (CAS 3069-42-9) is available (Asta-Werke, 1987). In this limit test three White Russian rabbits of each sex were exposed to 2000 mg/kg bw of the test substance for 24 h via occlusive dressing and observed for 14 days post-application. The test substance did not produce systemic toxic effects. The treated skin showed redness after removal of the test substance. Skin scales were observed between day 3 and day 7 post-application with the test substance, but were fully reversible within 13 days post-application. No remarkable changes or differences in body weights were recorded. No abnormalities were detected at necropsy at the end of the 14-day observation period. Thus, the acute dermal LD50 value for males/females was considered to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral and dermal toxicity of the registered substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008 and are therefore conclusive but not sufficient for classification.

No data on acute inhalation is available.