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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study predates GLP but is sufficiently documented, meets generally accepted scientific principles and is acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 4 males tested at each dose; no follow-up assessment in females. Occlusive covering. Limited detail of clinical examinations and pathology.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(trimethoxysilyl)propylamine
EC Number:
237-511-5
EC Name:
3-(trimethoxysilyl)propylamine
Cas Number:
13822-56-5
Molecular formula:
C6H17NO3Si
IUPAC Name:
3-(trimethoxysilyl)propylamine

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no details
- Age at study initiation: 3-5 months
- Weight at study initiation: no details
- Fasting period before study: no details
- Housing: no details
- Diet (e.g. ad libitum): no details
- Water (e.g. ad libitum): no details
- Acclimation period: no details

ENVIRONMENTAL CONDITIONS
no details

IN-LIFE DATES: no details

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no details
- % coverage: no details
- Type of wrap if used: polyethylene

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance 'removed' after exposure
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4, 8 and 16 ml/kg bw (no further details).
- Concentration (if solution): neat
Duration of exposure:
24 h
Doses:
4, 8 and 16 ml/kg bw
No. of animals per sex per dose:
4 males/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no details
- Necropsy of survivors performed: apparently yes - very limited details given
- Other examinations performed: body weight - very limited details given

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
11.3 mL/kg bw
95% CL:
5.19 - 24.7
Mortality:
See table 1.
Clinical signs:
other: None reported.
Gross pathology:
See table 1; no further details given.
Other findings:
- Organ weights: not measured
- Histopathology: see table 1
- Potential target organs: insufficient detail available

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity, and time range within which mortality occurred

Dose
(ml/kg bw)

Mortality (# dead/total)

Time range of deaths (days)

Local skin effects

Pathology

Body weight change (g)

[as reported – initial body weight not given]

4

0/2

-

Scabbing in1 of 2 on day 14

In fatalities: discoloured liver  (mottled red and tan, white spots) and kidneys (tan).

In survivors: discoloured livers (dark red) and kidneys (mottled tan and red).

4; 61

8

1/4

9

Erythema, oedema, desquamation and necrosis; full details not presented.

-784 to 239 (mean 239)

16*

3/4

1, 2, 4

Erythema, oedema, desquamation, necrosis and fissuring in the survivor; full details not presented.

59

* two different samples of test substance used for 2 rabbits in each case

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
A brief summary of a limited study, for which neither guideline nor GLP status were reported, recorded an LD50 in the rabbit of 11.3 ml/kg bw.