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Toxicological information

Acute Toxicity: inhalation

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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
28.35 mg/L air
Exp. duration:
4 h
Remarks on result:
other: Klimish statistic assessment
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
Sex:
male/female
Dose descriptor:
LC50
Effect level:
34.13 mg/L air
Exp. duration:
4 h
Remarks on result:
other: Klimish statistic assessment
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
Sex:
female
Dose descriptor:
LC50
Effect level:
40.78 mg/L air
Exp. duration:
4 h
Remarks on result:
other: Klimish statistic assessment
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:
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