Reaction mass of 1,3-dimethyl-1,1,3,3-tetraphenyldisiloxane and 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane and 1,3,3,5,5,7-hexamethyl-1,1,7,7-tetraphenyltetrasiloxane

Endpoint summary

Description of key information

The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

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:

July - September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Velaz, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 178 - 194 g
- Fasting period before study: yes
- Housing: housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning
- Diet: laboratory food ssniff (Spezialdiäten GmbH, Germany), offered at recommended doses each day approximately at the same time
- Water (ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.0 - 23.4
- Humidity (%): 54.7 ± 2.3
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.8 mL/kg

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2, 4 h after administration + daily for the next 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period

Gross pathology:

no findings

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
The test item is classified in GHS Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The test item was administered to 6 female Wistar rats at a limit dose of 2000 mg/kg. All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.The limit dose did not cause death or evident signs of toxicity. During the follow up period, no other signs of intoxication, change of health, nor any other adverse reactions were displayed.The body weight of animals increased during the study.The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

OECD Guideline Study

Justification for classification or non-classification

The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item is classified in GHS Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.