[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is taken from a secondary source

Data source

Reference

Reference Type:

other: Secondar source

Title:

SIDS Initial Assessment Report For SIAM 17

Author:

OECD-SIAM

Year:

2003

Bibliographic source:

OECD SIDS, SIAM, 2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1966

Principles of method if other than guideline:

The study appears to be similar to OECD TG 402, but the level of detail in the report is such that this cannot be confirmed.

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-(trimethoxysilyl)propyl)ethylenediamine

EC Number:

217-164-6

EC Name:

N-(3-(trimethoxysilyl)propyl)ethylenediamine

Cas Number:

1760-24-3

Molecular formula:

C8H22N2O3Si

IUPAC Name:

(2-Aminoethyl)(3-(trimethoxysilyl)propyl)amine

Test material form:

liquid

Specific details on test material used for the study:

Not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) No data Avaiable
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data Avaiable
- Rationale for use of males (if applicable) No data Avaiable
- Age at study initiation: three to five months
- Weight at study initiation: No data Avaiable
- Fasting period before study: No data Avaiable
- Housing: No data Avaiable
- Historical data: No data Avaiable
- Diet (e.g. ad libitum): No data Avaiable
- Water (e.g. ad libitum): No data Avaiable
- Acclimation period: No data Avaiable
- Microbiological status when known No data Avaiable
- Method of randomisation in assigning animals to test and control groups No data Avaiable

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data Avaiable
- Humidity (%): No data Avaiable
- Air changes (per hr): No data Avaiable
- Photoperiod (hrs dark / hrs light): No data Avaiable

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used: polyethylene sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): done
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16.0 (2 animals) or 8.0 (4 animals) ml/kg
- Concentration (if solution): No data avaiable
- Constant volume or concentration used: yes/no No data avaiable
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit): No data avaiable
- Concentration (if solution): No data avaiable
- Lot/batch no. (if required): No data avaiable
- Purity:No data avaiable

Duration of exposure:

24 hours

Doses:

16 and 8 ml/kg bw

No. of animals per sex per dose:

8 ml/kg: 4
16 ml/kg: 2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: No data avaiable
- Necropsy of survivors performed: yes
- Clinical signs including body weight No data avaiable
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

average method based

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

16 mL/kg bw

Based on:

test mat.

95% CL:

>= 8 - <= 16

Remarks on result:

other: Effective level was found to be 16 ml/kg bw

Mortality:

THe LD50 was found to be 16mL/kg bw

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

The surviving animal dosed at 16.0 mg/kg and three of the four animals dosed at 8.0 mg/kg gained weight during the study

Gross pathology:

Gross Pathology observations included congested lungs, liver and spleen, and pale kidneys

Other findings:

Not specified

Any other information on results incl. tables

Table No 1 Mortality Rate

Dose (ml/kg)	Death	Days to Death
16	1/2	7
8	0/4	Not applicable

Applicant's summary and conclusion

Interpretation of results:

other: Not Classified

Conclusions:

The LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine ( CAS number: 1760-24-3) was at least 16.0 ml/kg body weight in male rabbits in an acute dermal toxicity study reported as a summary, but similar to OECD 402 (not GLP, reliability score 4).

Executive summary:

In accordance with guideline 402, an acute dermal toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl] (CAS number: 1760-24-3)was conducted using Rabbit New Zealand species at dose levels 16 and 8 ml/kg bw.

The RA sample was applied to all animals in groups 16ml/kg bw (2 animals) and 8 ml/kg bw (4 animals ) mortality was noted one out of two animals was found to be dead on 7th day of observation at a dose range of 16ml/kg bw, while all the 4 animals were survived at a dose range of 8 ml/kg bw

Necropsy findings, including Gross Pathology observations, included congested lungs, liver and spleen, and pale kidneys

The LD50 value of the test sample was 16.0 ml/kg bw for animals. Hence the test chemical cannot be classified according to CLP criteria.