1,1-dichloroethylene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Old study, no data on environmental conditions, nor air renewal frequency. However conducted according to current guidelines. Monitoring of concentrations, number of tested animals are available.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

no data on environmental conditions, no air renewal frequency

Principles of method if other than guideline:

no data

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1-dichloroethylene

EC Number:

200-864-0

EC Name:

1,1-dichloroethylene

Cas Number:

75-35-4

Molecular formula:

C2H2Cl2

IUPAC Name:

1,1-dichloroethene

Details on test material:

- Name of test material (as cited in study report): Vinylidene chloride and 1,1-dichloroethene
- Molecular formula (if other than submission substance): CH2=C Cl2
- Substance number a cited in the report: 78/621
- Physical state: colorless liquid
- Analytical purity: 99.7%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF-Zucht, Firma WIGA, Sulzfeld
- Diet: Herilan MRH (Firma H. EGGERSMANN KG, Rinteln/Weser) from ad libitum
- Water ad libitum
- Forage ad libitum
- 10 males and 10 females per dose batch with one dose which demonstrate a no effect level.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Remarks:

steel and glass inhalation room

Vehicle:

other: no data

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 520 l.
- Method of conditioning air: 1,1-dichloroethene vapour mixed with fresh air

TEST ATMOSPHERE

Analytical sample: Total Hydrocarbon analyzed with automatic sampling unit
- Speed sampling: 2.2 ml/sec.
- Analytical flow: 25 l/h.
- Sensor place: Chamber

- Brief description of analytical material used:
* Sensor: Ratfisch with V2A-Rohr 2 mm
* Oven temperature: 120 °C
* Thermometer: 120 °C
* Air: 82%
* Hydrogen: 21%
* Verification with test gas cylinders

Analytical verification of test atmosphere concentrations:

yes

Remarks:

See measured concentrations in Table 1

Duration of exposure:

4 h

Concentrations:

See measured and nominal concentrations in Table 1

No. of animals per sex per dose:

10 animals per sex per dose (see details in Table 1)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: weekly (see Table 2-3)
- Necropsy of survivors performed: yes

Statistics:

The statistical analysis of the experiment is in accordance with DJ Finney probitanalysis.
D.J. Finney; Probitanalysis 1971, Seite 1 - 150. Published by the Syndics of the Cambrige University Press, Bentley House, 200 Euston Road, London N.W. 1.

Results and discussion

Preliminary study:

no data

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

28.35 mg/L air

Exp. duration:

4 h

Remarks on result:

other: Klimish statistic assessment

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

113.42 mg/L air

Exp. duration:

1 h

Remarks on result:

other: calculated according to Haber's rule

Effect levels 3

Sex:

male/female

Dose descriptor:

LC50

Effect level:

34.13 mg/L air

Exp. duration:

4 h

Remarks on result:

other: Klimish statistic assessment

Effect levels 4

Sex:

male/female

Dose descriptor:

LC50

Effect level:

136.52 mg/L air

Exp. duration:

1 h

Remarks on result:

other: calculated according to Haber's rule

Effect levels 5

Sex:

female

Dose descriptor:

LC50

Effect level:

40.78 mg/L air

Exp. duration:

4 h

Remarks on result:

other: Klimish statistic assessment

Effect levels 6

Sex:

female

Dose descriptor:

LC50

Effect level:

168.13 mg/L air

Exp. duration:

1 h

Remarks on result:

other: calculated according to Haber's rule

Mortality:

Mortality rate: see Table 1

Clinical signs:

other: Batch 1 and 2: - Narcosis (on survivors of more than three days) Batch 2 and 3: - Apathy and shock as breathing, after 24 h

Body weight:

Most animals gain weight. See Table 2-3

Gross pathology:

no data

Other findings:

All animals show toxicological effects as:
- Heart: acute contraction of ventricle
- Pulmonary: bleeding / local inflation

Any other information on results incl. tables

Table 1 : Mortality rate for each batch according to VDC concentration

Batch number	Concentration (ppm)		Concentration (mg/l)		Mortality rate
	measured	nominal	measured	nominal	male	female
1	13850	15000	54.96	59.52	10/10	10/10
2	9000	9000	35.71	35.71	6/10	0/10
3	4730	5000	18.77	19.84	2/10	1/10
4	1970	2000	7.82	7.94	0/10	0/10

Table 2 : Absolute body weight development

Average of animals weight		Before test		After 7 days		After 14 days
		male	female	male	female	male	female
Batch 1	Weight in g.	273	222
	Number of animals	10	10
Batch 2	Weight in g.	245	203	251	202	291	217
	Number of animals	10	10	4	10	4	10
Batch 3	Weight in g.	190	182	231	194	275	219
	Number of animals	10	10	8	9	8	9
Batch 4	Weight in g.	234	202	267	209	290	214
	Number of animals	10	10	10	10	10	10
Control	Weight in g.	160	156	209	173	265	196
	Number of animals	10	10	10	10	10	10

Table 3 : Relative body weight development

Average of animals weight		Before test		After 7 days		After 14 days
		male	female	male	female	male	female
Batch 1	Weight in g.	273	222
	Number of animals	10	10
Batch 2	Weight in g.	245	203	6	-1	46	14
	Number of animals	10	10	4	10	4	10
Batch 3	Weight in g.	190	182	41	12	85	37
	Number of animals	10	10	8	9	8	9
Batch 4	Weight in g.	160	156	49	17	105	40
	Number of animals	10	10	10	10	10	10
Control	Weight in g.	160	156	49	17	105	40
	Number of animals	10	10	10	10	10	10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information LC50>20 mg/l Criteria used for interpretation of results: EU

Conclusions:

The LC50 of 1,1-dichloroethene for male and female rats is respectively 28.35 and 40.78 mg/L air.

Executive summary:

The acute inhalation toxicity of 1,1 -dichloroethene in male and female Sprague-Dawley male rats by inhalation was tested. Animals were exposed to 1,1 -dichloroethene vapour during 4h. There were 10 animals per sex and per dose. The LC50 for male and female rats was respectively 28.35 and 40.78 mg/L air.

The animals were observed during 2 weeks after treatment. At the end of observation period, remaining animals were killed and a pathology research was performed.

Observed effects were:

- Heart: acute contraction of ventricle

- Pulmonary: bleeding / local inflation

- Narcosis

- Apathy and shock as breathing