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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (pre-GLP, short observation period)

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 10 rats per sex and dose were treated simultaneously by gavage 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 type:
standard acute method

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:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Mean body weight at study initiation:
0.2 ml/kg bw dose group: males: 231 g / females: 196 g
1.6 ml/kg bw dose group: males: 231 g / females: 200 g
3.2 ml/kg bw dose group: males: 247 g / females: 191 g
6.4 ml/kg bw dose group: males: 244 g / females: 191 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: traganth
Details on oral exposure:
DOSAGE PREPARATION:
- Stock solutions prepared:
2% for the 0.2 ml/kg bw dose group;
20% for the 1.6 ml/kg bw dose group;
30% for the 3.2 and 6.4 ml/kg bw dose groups.

- Dose volume applied:
10 ml/kg bw of the 2% stock solution for the 0.2 ml/kg bw dose group;
8 ml/kg bw of the 20% stock solution for the 1.6 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:
0.2; 1.6; 3.2; 6.4 ml/kg bw,
corresponding to 177; 1413; 2827; 5653 mg/kg bw (calculated using the relative density of 0.8833 g/cm³ (@ 20°C))
No. of animals per sex per dose:
10
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 that died performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 653 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:
> 6.4 mL/kg bw
Based on:
test mat.
Remarks on result:
other: original data
Mortality:
No mortalities in 0.2, 1.6 and 3.2 ml/kg bw dose groups; 1/20 (one female) in the 6.4 ml/kg bw dose group (see table below).
Clinical signs:
other: 0.2 ml/kg bw dose group: No symptoms. 1.6 ml/kg bw dose group: Immediately after application high stepping gait, agitated behavior, accelerated respiration and in the afternoon squatting posture, piloerection, eyelid closure and hardly visible respiration
Gross pathology:
Animal that died:
- serously smeared mouth, strongly extended gastrointestinal tract with decay

Animals sacrificed:
- nothing abnormal detected

Any other information on results incl. tables

Mortality data:

Dose (ml/kg)

0.2

1.6

3.2

6.4

Dose (mg/kg)

177

1413

2827

5653

 

 

 

 

 

Males: Number of animals

10

10

10

10

Dead animals after:

 

 

 

 

1 h

0

0

0

0

1 d

0

0

0

0

2 d

0

0

0

0

7 d

0

0

0

0

 

 

 

 

 

Females: Number of animals

10

10

10

10

Dead animals after:

 

 

 

 

1 h

0

0

0

0

1 d

0

0

0

0

2 d

0

0

0

0

7 d

0

0

0

1

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of the test the LD50 for male and female rats after oral application is > 6.4 ml/kg bw/5653 mg/kg bw.