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Description of key information

The key study for acute oral toxicity, conducted according to the appropriate OECD Test Guideline 423 and in compliance with GLP with the registered substance  3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5- divinyltrisiloxane, reports an LD50 value of >5000 mg/kg bw in female rats (NOTOX, 2011a).  

The key study for acute dermal toxicity, conducted according to the appropriate OECD Test Guideline 402 and in compliance with GLP with the registered substance  3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5- divinyltrisiloxane, reports an LD50 value of >2000 mg/kg bw in rats (Harlan, 2012).  

The acute toxicity study via the inhalation route required in Section 8.5.2 of REACH Regulation Annex VIIII does not need to be conducted according to Column 2 of Section 8.5 as reliable data via the oral and dermal routes are available.

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:
09 August 2011 - 25 August 2011
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
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: Charles River Deutschland, Germany
- Age at study initiation: Young adults, ca. 8 weeks
- Fasting period before study: over night
- Housing: Group housing of 3 per cage, in Makrolon cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20.9
- Humidity (%): 40-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12 hours light /12 hours dark

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.556 ml/kg

Doses:
Single dose, 5000 mg/kg bw
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were taken on day 1 (pre-administration), 8 and 15. Clinical signs were recorded at periodic intervals on the day of dosing and once daily thereafter until day 15. Mortality/viability was observed twice daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Description of all internal macroscopic abnormalities were recorded.
Statistics:
No statistical analysis was performed.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities.
Clinical signs:
All animals showed hunched posture on day 1. Three animals also showed piloerection on day 1.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic postmortem examination of the animals.
Other findings:
None reported.
Interpretation of results:
GHS criteria not met
Conclusions:
An LD50 value of >5000 mg/kg bw is reported in female rats, in a reliable study conducted according to the appropriate OECD Test Guideline 423 and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: RccHan:WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratoies, The Netherlands
- Age at study initiation: 8 weeks (males) and 10 weeks (females)
- Weight at study initiation: 227.3-237.2g (males), 208.5-219.1g (females)
- Housing: In groups of five per sex in Makrolon type-4 cages during acclimatization. Individually in Makrolon type-3 cages during treatment and observation. Cages were equipped with wire mesh tops and standard softwood bedding.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light /12 hours dark

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the back
- Type of wrap if used: The test item was applied evenly on the intact skin with a syringe and covered with a surgical gauze pad (ca. 5x5cm). The gauze pad was held in contact with skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and an elastic adhesive restrainer bandage wrapped around the abdomen.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml/kg, calculated based on specific density of 0.9 g/mL


Duration of exposure:
24 hours
Doses:
2000 mg/kg
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 and weighing:The animals were examined daily during the acclimatisation period and mortality, viability, clinical signs and local dermal signs were recorded. All animals were examined for clinical signs before treatment and approximately 0.5, 1, 2, 3 and 5 hours after treatment on test day 1 (with the clinical signs) and twice daily during test days 2-15. Body weights were recorded on test day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and macroscopically examined.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:
Statistics:
No statistical analysis was performed.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No intercurrent deaths occurred during the study.
Clinical signs:
No clinical signs were observed throughout the entire observation period. Slight erythema was observed in one of five males and in one of five females after test item application on test day 2. This sign of skin irritation was reversible in both animals. No local dermal signs were observed in any animal from test day 3 until the end of the observation period.
Body weight:
Two females slightly lost body weight after treatment, one of them in the first week after treatment, the second in both weeks after treatment. Otherwise the body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of >2000 mg/kg bw is reported in a reliable study, conducted according to an appropriate OECD Test Guideline 402 and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

An LD50 value of >5000 mg/kg bw is reported in female rats, in a reliable study conducted according to the appropriate OECD Test Guideline 423 and in compliance with GLP with the registered substance  3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane (NOTOX, 2011a). There were no mortalities. All animals showed hunched posture on day 1. Three animals also showed piloerection on day 1. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. No abnormalities were found at macroscopic postmortem examination of the animals.

An LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to the appropriate OECD Test Guideline 402 and in compliance with GLP with the registered substance  3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5- divinyltrisiloxane (Harlan, 2012). There were no mortalities. No clinical signs were observed throughout the entire observation period. Slight erythema was observed in one of the five males and in one of the five females after test item application on test day 2. This sign of skin irritation was reversible in both animals. No local dermal signs were observed in any animal from test day 3 until the end of the observation period. Two females slightly lost body weight after treatment, one of them in the first week after treatment , the second in both weeks after treatment. Otherwise the body wight of the animals was within the range commonly recorded for this strain and age. No abnormalities were found at macroscopic postmortem examination of the animals.


Justification for classification or non-classification

Based on the available information, no classification is required for acute toxicity for 3,3-bis[(dimethyvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane in accordance with Regulation (EC) No 1272/2008.