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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl hydrogen maleate
EC Number:
231-048-2
EC Name:
2-ethylhexyl hydrogen maleate
Cas Number:
7423-42-9
Molecular formula:
C12H20O4
IUPAC Name:
2-ethylhexyl hydrogen maleate
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
(SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 98 - 126 g (mean: 108 g)
- Fasting period before study: The rats were not fed 16 hours before the application. 2 hours after administration of the product, the rats were given food again.
- Housing: The animals were kept in plastic cages on wood shavings.
- Diet: ALTROMIN 1324 (Altrogge), ad libitum.
- Water: ad libitum


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4 %


Doses:
800, 1250, 1600 and 2000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At study initiation, after 7 days and after 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Statistics:
The LD50 was determined by probit analysis (method according to Linder and Weber); the confidence limits were determined according to CAVALLI-SFORZA.

Results and discussion

Preliminary study:
A preliminary test was carried out in which no gender differences could be detected. Therefore, the main test was performed with female rats only.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 411 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 293 - <= 1 539
Mortality:
Only in the lowest dose group of 800 mg/kg no mortality occured.

For details see section 'Any other information on results incl. tables'.
Clinical signs:
Deadly poisoned animals died under balance disorders and accelerated breathing in abdominal or sternal position.
Body weight:
No findings were observed.
Gross pathology:
No findings were observed.

Any other information on results incl. tables

Table 1: Results of the acute oral toxicity study with the test item

Dose [mg/kg]

Concentration in %

Number of dead animals/ Number of total animals

800

4

0/10

1250

4

2/10

1600

4

8/10

2000

4

10/10

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the conditions of this test an LD50 of 1411 mg/kg bw was determined in rats.
Executive summary:

In an acute oral toxicity study equivalent to OECD guidleline 401, female Wistar rats (10/dose) were orally administered with a 4% solution of the test substance in sesame oil by oral gavage.

The test animals received the test substance at doses of 800, 1250, 1600 and 2000 mg/kg and were observed for 14 days. None of the animals had died in the lowest dose group. 2/10 and 8/10 animals had died at a dose of 1250 mg/kg and 1600 mg/kg, respectively and all animals had died in the highest dose group. Deadly poisoned animals died under balance disorders and accelerated breathing in abdominal or sternal position. The necropsy of the dead animals and survivors was without findings. Based on these result, an acute oral LD50 of 1411 mg/kg was observed in rats.