N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not stated

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine

EC Number:

221-336-6

EC Name:

N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine

Cas Number:

3069-29-2

Molecular formula:

C8H22N2O2Si

IUPAC Name:

N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, SPF-Zucht, GERMANY
- Age at study initiation: 8-10 weeks
- Weight at study initiation: males 208 g (199-222); females 194 g (184-200)
- Fasting period before study: not stated
- Housing: Makrolon cages
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: not stated

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

other: 'head-nose' exposure (nose near to tube delivering test material)

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus: cylindrical plastic tubes
- Exposure chamber volume: 60 litres
- Method of holding animals in test chamber: not identified from report in German
- Source and rate of air: 800 l/h
- System of generating particulates/aerosols: not identified from report in German
- Method of particle size determination: Anderson-Kas-kadenimpaktor Mark III

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric
- Samples taken from breathing zone: unclear to this reviewer from report in German

TEST ATMOSPHERE (if not tabulated)
- particle size: see table 2
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD 1.0-1.1 micrometers. GSD 1.6-1.9

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

4 h

Concentrations:

3.7, 5.2 mg/l

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (3.7 mg/l males and females; 5.2 mg/l females); 28 days (5.2 mg/l males)
- Frequency of observations and weighing: observations 2/daily; weights weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Study report states LC50 as ca. 5.2 mg/l.

Mortality:

See table 1, below.

Clinical signs:

other: See table 1, below.

Body weight:

Impaired development of body weight.

Gross pathology:

Abnormalities of the lungs were reported in 3 males and 1 female at 3.7 mg/l and in 4 males and 2 females at 5.2 mg/l. Lungs were discoloured or patchy or with emission of foam on dissection. All organs were examined macroscopically and there were no other remarkable findings.

Any other information on results incl. tables

Table 1: Concentrations, exposure conditions and mortality per animals treated

Analytical Conc. (mg/L)	MMAD µm	GSD	Mortality (dead/total)*			Evident toxicity
			Males	Females	Combined
3.7	0.98-1.12	1.81-1.76	1/5	0/5	1/10	Irregular breathing, breathlessnes or noisy breathing, uncoordinated or staggering gait, ataxia, prostration, narrowed eye, sneezing, blood-coloured nasal discharge, decreased spontaneous activity, aggressive or withdrawn behaviour, sunken flanks. Impaired bodyweight development.
5.2	0.99-1.08	1.92-1.64	0/5	2/5	2/10

* 14 days observation except for males exposed at 5.2 where observation was for 28 days.

Table 2: Particle size distribution

Particle size µm	Particle spectrum % (duplicate measurements at two concentrations)
	3.7 mg/l (1)	3.7 mg/l (2)	5.2 mg/l (1)	5.2 mg/l (2)
<0.6	15.68	12.11	17.8	9.98
0.6-0.8	28.97	20.33	28.80	26.10
0.8-1.5	30.63	33.03	24.61	31.86
1.5-3.0	22.69	31.39	28.80	30.33
3.0-4.8	1.48	2.54	0	1.73
4.8-7.0	0.55	0.60	0	0
7.0-10.3	0	0	0	0
>10.3	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A reliable study conducted according to OECD Test Guideline 403 and in compliance with GLP, reported deaths of 2 of 10 rats exposed for 4h to 5.2 mg/l (aerosol). The LC50 for males and females was therefore >5.2 mg/l.