2-ethylhexyl hydrogen maleate

Endpoint summary

Description of key information

Acute toxicity, oral route: LD50 = 1411 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

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

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.

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.

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:

other: Deadly poisoned animals died under balance disorders and accelerated breathing in abdominal or sternal position.

Gross pathology:

No findings were observed.

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 411 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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 (Hochst AG, 1995).

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 this result, an acute oral LD50 of 1411 mg/kg was observed in rats.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008:
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test substance is classified as cat. 4, H302 (Harmful if swallowed) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.