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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15/01/2013 - 02/02/2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate
EC Number:
642-902-2
Cas Number:
163802-53-7
Molecular formula:
C12H22O5Si
IUPAC Name:
3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate
Constituent 2
Reference substance name:
2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester, (2E,4E)-
IUPAC Name:
2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester, (2E,4E)-
Constituent 3
Reference substance name:
3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
IUPAC Name:
3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: WISTAR rats Crl: WI(Han) (full barrier)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: males 237-259 g ; females 166-183 g
- Fasting period before study: none
- Housing: The rats were kept individually in IVC cages, type IP H, polysulphone cages on Altromin saw fibre bedding.
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): tap water, sulphur acidified to a pH value of approx. 2.8
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: gauze-dressing and non-irritating tape plus additional dressing

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg per body weight
- Constant volume or concentration used: yes


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 non-pregnant females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed on day 1 (prior to the application), on days 8 and 15. Observations for clinical signs were noted 30 minutes after application, then at 4 hours and then daily. Special attention was paid to changes in the skin and fur, eyes and mucous membranes, circulatory, respiratory, autonomic and central nervous system as well as somatomotor activity and behaviour pattern were examined.
- Necropsy of survivors performed: At the end of the study all the surviving animals were killed by overdosage with pentobabrital injected intraperitoneally. All gross pathological changes were recorded.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no cases of mortality during the 14-day study period.
Clinical signs:
There were cases of eschar or scratches from day 5 until day 12 in one male. The same effect was observed in 4 females from day 5 until days 9, 15, 7 and 12.
Body weight:
A slight gain of body weight was observed in both males and females during the 14-day study period.
Gross pathology:
No significant gross pathological changes were recorded in the tested animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study conducted to the OECD 402 and to GLP, the LD50 for 2,4-hexadienoic acid, 3-(trimethoxysilyl)propyl ester was > 2000 mg/kg bw in rats.

Executive summary:

The acute dermal toxicity following the application of a single dose of the test item was determined. The study was performed as a limit test according to OECD 402 and OPPTS 870.1200.

Five male and five female WISTAR Crl: (WI(Han) rats were selected for testing. The fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used. At least 10% of the body surface was cleared for the application. Prior to application, a detailed clinical observation was made for all animals.

The neat test item was applied uniformly over an area which was approximately 10% of the total body surface. The test item was held in contact with the skin by a dressing throughout the 24 hour period. The dressing consisted of a gauze-dressing and not-irritating tape and was fixed with an additional dressing in a suitable manner.

Under the conditions of the study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity but signs of irritation. Therefore, the dermal LD50 was determined to be >2000 mg/kg body weight.