[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-12-06 - 1995-04-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

by Umweltministerium Baden-Württemberg

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate

Molecular formula:

C27H60NPS2O2 C28H62NPS2O2 C29H64NPS2O2 (main component)

IUPAC Name:

Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate

Test material form:

liquid

Details on test material:

Before Substance ID change known as CAS 71888-91-0 EC 276-159-7

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna, Suddeutsche Versuchstierfarm, Oberer Bann 37, D-78532 Tuttlingen
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 202 - 245g (females), 207 - 245 g (males)
- Fasting period before study: yes, overnight
- Housing: The rats housed individually in Macrolon cages (area 800 cm², height 17 cm)
- Diet (e.g. ad libitum): Haltungsdiat "ALMA 0801 H 1003", twice 8 g daily
- Water (e.g. ad libitum): Free access by daily changing of the watering bottles
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12:12

Administration / exposure

Route of administration:

oral: capsule

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000, 2800, or 3920 mg test item in each 1000µl pure sesame oil
- Amount of vehicle (if gavage): 1000µl
- Purity: pure

MAXIMUM DOSE VOLUME APPLIED: no exceeding the limit volume of 1 ml/100 g body weight

Doses:

2000, 2800, or 3920 mg/kg

No. of animals per sex per dose:

Group I and II (2000 resp. 2800 mg/kg, each group consists of 5 male and 5 female Sprague-Dawley rats)
Group III (3920 mg/kg, the group consists of 5 male Sprague-Dawley rats)
Control group (sesame oil): (the group consists of 2 male and 2 female Sprague-Dawley rats)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The following times of death after administration of the test item are recorded:
2000 mg/kg:
rat No. 636 3 hours
2800 mg/kg:
rat No. 653 and 654 10 minutes
rat No. 651 1.5 hours
rat No. 644 2 hours
rat No. 642 3 hours
3920 mg/kg:
rat No. 656 2.5 hours
The LD50 value of the test item turned out to be unquantifiable in this toxicity study because of the non-linear dose relationship of the mortality rate observed. However, it can be deduced from the mortality rate almost certainly that the LD50 for rats of both sexes is greater than 2000 mg/kg body weight.

Clinical signs:

other: Acute toxicological symptoms attributed to the exposure to the test item could be observed in five rats of group I (2000 mg/kg) and in all rats of group II (2800 mg/kg) and of group III (3920 mg/kg).

Gross pathology:

The post-mortem findings of all 25 rats of the test show no macroscopical organ changes in the pathological examination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

EU implementation

Conclusions:

The study was performed on the registered substance itself according to OECD 401 under GLP, the report is well documented. Hence, the results can be considered as sufficiently reliable to assess the acute toxicity of the test item to rats via the oral route. The LD50 was determined to be > 2000 mg/kg, hence, the substance does not need to be classified as acutely toxic acc. Regulation 1272/2008.

Executive summary:

The acute oral toxicity of the test item was determined acc. OECD TG 401 under GLP.

The test substance was administered orally in a single dose to three groups of Sprague-Dawley rats:

Group I (10 rats, 5 male and 5 female): 2000 mg/kg applied

Group II (10 rats, 5 male and 5 female): 2800 mg/kg applied

Group III (5 rats, male): 3920 mg/kg applied

 

Mortality

group	I	II	III
	2000	2800	3920
	mg/kg	mg/kg	mg/kg
mortality
number
male	1 outof 5	2 out of 5	1 out of 5
female	0 outof 5	3 out of 5	Not tested

 

Acute toxicological symptoms attributed totheexposure to the test item could be observed in five rats of group I (2000 mg/kg) and in all rats of group II (2800 mg/kg) and of group III (3920 mg/kg). The post-mortem findings of all 25 rats of the test show no macroscopical organ changes inthepathological examination. The LD 50 value of the test item turned out to be unquantifiable in this toxicity study because ofthenon-linear dose relationship of the mortality rate observed. However, it can be deduced from the mortality rate almost certainlythatthe LD50 for rats of both sexes is greater than 2000 mg/kg body weight. Testing of further groups was omitted due to animal welfare.

Based on the obtained results, the substance does not need to be classified as acutely toxic acc. Regulation 1272/2008.