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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-05-10 to 1989-11-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine
EC Number:
253-634-7
EC Name:
1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine
Cas Number:
37697-65-7
Molecular formula:
C13H33N3Si
IUPAC Name:
{bis[(butan-2-yl)amino](methyl)silyl}(butan-2-yl)amine
Test material form:
other: viscous liquid

Test animals

Species:
rat
Strain:
other: Ico rat - OFA.SD. (IOPS Caw)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, France
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 206-250 g
- Fasting period before study: No information.
- Housing: individually in type FI polycarbonate cages.
- Diet (e.g. ad libitum): complete pelleted rat-mouse maintenance diet, ad libitum
- Water (e.g. ad libitum):softened and filtered, ad libitum
- Acclimation period: Seven days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-25
- Humidity (%): 50 - 91
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: approximately 10% of the total body surface area.
- Type of wrap if used: Test article was kept in place by means of a semi-occlusive dressing composed of a perforated adhesive bandage.


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.39 ml/kg
- Constant volume or concentration used: yes


Duration of exposure:
24 hours
Doses:
2008 mg/kg bw/day
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 15 minutes after administration of the test substance, at 1, 2 and 4 hours, and then daily for the 14 day observation period. The animals were weighed immediately before application of the test material, then at day 8 and 15.
- Necropsy of survivors performed: yes, on day 15. The abdominal and thoracic cavities were opened and particular attention was paid to the liver, heart, kidneys, lungs and skin of the application area.
- Other examinations performed: clinical signs: changes in the fur, in the treated skin, the eyes, mucous membranes, respiratory system, circulated system, autonomic and central nervous system, as well as somato-motor activity and behaviour. Shivering, convulsions, salivation, diarrhoea, lethargy, sleeping and coma were noted with particular attention. Body weight was recorded before application and at day 8 and 15.
Statistics:
The body weights of the animals were evaluated, for each sex, calculating the mean of the values obtained, the standard deviation, and the variation coefficient, which indicates the homogeneity of the data. No other statistics performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 008 mg/kg bw
Mortality:
No deaths.
Clinical signs:
There were no changes in behaviour or clinical signs in any of the treated animals.
Body weight:
There were no treatment-related effects on body weight.
Gross pathology:
There were no macroscopic findings that could be associated with treatment.
Other findings:
- Cutaneous examinations: According to the description of the study authors, 'a blackish aspect' of the cutaneous surface to the application area of the test article was noted in all the rats on day 2. Then the presence of superficial eschar formations was noted in all the rats from day 3 onwards and up to the end of the observation period. No presence of oedema was noted during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study conducted to OECD TG 402 and in compliance with GLP, the LD50 for 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine was >2008 mg/kg bw.
Executive summary:

SBA 52 was applied, once only, as supplied and at the dose level of 2008 mg/kg bw/day, by the cutaneous route under a semi-occlusive dressing, in the Sprague-Dawley rat (five/sex). Mortality and abnormal clinical signs were noted 15 minutes after application, then at 1, 2 and 4 hours, and then daily for the 14 day study period. All the animals were weighed immediately before the skin application of the test substance, and on day 8 and 15. A necropsy was performed for all the animals after the 14 day study period and the final observation. There were no deaths. A blackish aspect of the cutaneous surface to the application area of the test article was noted in all the rats on day 2. Then the presence of superficial eschar formations was noted in all the rats from day 3 onwards and up to the end of the observation period. No presence of oedema was noted during the study. The LD50 was greater than 2008 mg/kg bw.