Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF-TEST: The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Constituent 1
Reference substance name:
Ethylhexylchloride
IUPAC Name:
Ethylhexylchloride
Details on test material:
- Name of test material (as cited in study report): Ethylhexylchloride
- Physical state: liquid
- Purity: ca. 98%

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kisslegg
- Age at study initiation: young adults
- Mean body weight at study initiation:
0.2 ml/kg bw dose group: males: 37.6 g / females: 30.2 g
0.4 ml/kg bw dose group: males: 34.6 g / females: 31.0 g
0.8 ml/kg bw dose group: males: 37.4 g / females: 30.2 g
1.0 ml/kg bw dose group: males: 34.4 g / females: 30 g
1.25 ml/kg bw dose group: males: 35.6 g / females: 29.6 g
1.6 ml/kg bw dose group: males: 38.0 g / females: 31.0 g
2.0 ml/kg bw dose group: males: 33.8 g / females: 30.6 g
2.5 ml/kg bw dose group: males: 34.2 g / females: 29.4 g
3.2 ml/kg bw dose group: males: 39.4 g / females: 27.6 g
6.4 ml/kg bw dose group: males: 37.4 g / females: 31.2 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: traganth
Details on exposure:
DOSAGE PREPARATION:
- Stock solutions prepared:
2% for the 0.2 ml/kg bw dose group,
4% for the 0.4 ml/kg bw dose group,
8% for the 0.8 ml/kg bw dose group,
10% for the 1.0 and 1.25 ml/kg bw dose groups,
20% for the 1.6, 2.0 and 2.5 ml/kg bw dose groups,
30% for the 3.2 and 6.4 ml/kg bw dose groups.

- Dose volume applied:
10.0 ml/kg bw of the 2% stock solution for the 0.2 ml/kg bw dose group;
10.0 ml/kg bw of the 4% stock solution for the 0.4 ml/kg bw dose group;
10.0 ml/kg bw of the 8% stock solution for the 0.8 ml/kg bw dose group;
10.0 ml/kg bw of the 10% stock solution for the 1.0 ml/kg bw dose group;
12.5 ml/kg bw of the 10% stock solution for the 1.25 ml/kg bw dose group;
8.0 ml/kg bw of the 20% stock solution for the 1.6 ml/kg bw dose group;
10.0 ml/kg bw of the 20% stock solution for the 2.0 ml/kg bw dose group;
12.5 ml/kg bw of the 20% stock solution for the 2.5 ml/kg bw dose group;
10.6 ml/kg bw of the 30% stock solution for the 3.2 ml/kg bw dose group;
21.3 ml/kg bw of the 30% stock solution for the 6.4 ml/kg bw dose group.
Doses:
200; 400; 800; 1000; 1250; 1600; 2000; 2500; 3200; 6400 ml/kg bw,
corresponding to 177; 353; 707; 883; 1104; 1413; 1767; 2208; 2827; 5653 mg/kg bw (calculated using the relative density of 0.8833 g/cm³ (@ 20°C))
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days;
- The animals were observed for mortality and clinical signs of toxicity;
- Frequency of observations: Several times on the application day, thereafter once each working day;
- Body weights were only recorded at the beginning of the study;
- Necropsy of survivors and animals which died performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 590 mg/kg bw
Based on:
test mat.
Remarks on result:
other: calculated from original data using the relative density of 0.8833 g/cm³
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1.8 mL/kg bw
Based on:
test mat.
Remarks on result:
other: original data
Mortality:
see table below.
Clinical signs:
Dyspnoea, tremor, twitching, convulsions, staggering, abdominal position.
Body weight:
Body weights were not recorded during and at the end of the observation period.
Gross pathology:
Intraabdominal adhesions

Any other information on results incl. tables

Mortality data:

Dose (ml/kg)

0.2

0.4

0.8

1.0

1.25

1.6

2.0

2.5

3.2

6.4

Dose (mg/kg)

177

353

707

883

1104

1413

1413

1767

2827

5653

 

 

 

 

 

 

 

 

 

 

 

Males: Number of animals

5

5

5

5

5

5

5

5

5

5

Dead animals after:

 

 

 

 

 

 

 

 

 

 

1 h

0

0

0

0

0

0

0

0

0

0

1 d

0

0

0

0

0

2

2

3

5

5

2 d

0

0

0

0

1

3

2

4

5

5

7 d

0

0

0

0

2

3

4

5

5

5

14 d

1

n.d.

n.d.

2

3

4

4

5

5

5

 

 

 

 

 

 

 

 

 

 

 

Females: Number of animals

5

5

5

5

5

5

5

5

5

5

Dead animals after:

 

 

 

 

 

 

 

 

 

 

1 h

0

0

0

n.d.

0

0

0

0

0

0

1 d

0

0

0

n.d.

0

0

1

2

2

5

2 d

0

0

0

n.d.

0

0

2

5

5

5

7 d

0

0

0

n.d.

1

0

3

5

5

5

14 d

0

n.d.

n.d.

n.d.

2

0

4

5

5

5

n.d.: not determined

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study the LD50 for male an female mice after i.p. application is approximately 1.8 ml/kg bw/1590 mg/kg bw.