Octaphenylcyclotetrasiloxane

Endpoint summary

Description of key information

In an acute oral toxicity study conducted according to OECD Test Guideline 423 and in compliance with GLP, the reported LD₅₀ value for octaphenylcyclotetrasiloxane was >2000 mg/kg bw (HSRL, 2011).

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:

2011-07-13 to 2011-08-31

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)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Orient BIO Co., Korea
- Age at study initiation: 9 weeks old
- Weight at study initiation: 188.0 - 215.0 g (Step 1), 222.0 - 234.7 g (Step 2)
- Fasting period before study: food was removed for 1 day before administration, water was supplied
- Housing: 2 -3 animals in stainless steel cages
- Diet: pellet diet for rat, ad libitum
- Water: filtered and UV irradiated water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 10-15/ hour
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/mL in corn oil for step 1 and 2
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Following administration of 2000 mg/kg bw in step 1, no deaths occurred (Limit test).

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Step 1: 3 females
Step 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were examined at 4 hours post administration, then daily during the 14-day study period. Body weights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and macroscopic examination at necropsy

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the 14-day study period.

Clinical signs:

other: No clinical signs of toxicity were noted in any of the animals.

Gross pathology:

No macroscopic abnormalities were noted at necropsy in any of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study the reported LD50 value for octaphenylcyclotetrasiloxane was >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute oral toxicity test conducted according to OECD Test Guideline 423 and in compliance with GLP, the reported LD₅₀ value for octaphenylcyclotetrasiloxane was >2000 mg/kg bw (HSRL, 2011). There were no deaths, adverse clinical signs, effects on body weight and no macroscopic abnormalities were noted at necropsy in any of the animals.

Justification for classification or non-classification

Based on the available acute oral toxicity test octaphenylcyclotetrasiloxane does not require classification for acute toxicity according to Regulation (EC) No. 1272/2008.