N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23. Feb - 26. March 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed and reported study equivalent to OECD guideline 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

4 days acclimatisation

GLP compliance:

no

Remarks:

performed before GLP guidelines

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

ALB 206

IUPAC Name:

ALB 206

Details on test material:

no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS (Wistar Hannover KFM)
- Source: Kleintier-Farm Madoerin AG, Füllinsdorf, Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 170-220 g
- Fasting period before study: overnight
- Housing: in groups of 5 (males respectively females) in Macrolon cages (type III)
- Diet (e.g. ad libitum): Standard Kliba 343 Rat Maintenance Food (Klingentalmühle, Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 55+/-10%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

Before treatment the suspension (in PEG 400) was homogeneously dispersed with an ultra-turrax and during treatment was kept stable with a magnetic stirrer.

Doses:

5000 mg/kg bw
7000 mg/kg bw
10000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily clinical observations after application / weighing once weekly
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the Logit Model.

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Remarks on result:

other: no effects

Mortality:

no deaths occurred

Clinical signs:

other: no significant effects

Gross pathology:

no macroscopic findings

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of Hostavin 3206 (LD50) was > 10000 mg per kg body weight. Based on the result of this study Hostavin 3206 is not subject for labelling and classification requirements according to regulatory requirements.

Executive summary:

The acute oral LD50 of Hostavin 3206 in rats of both sexes observed over a period of 14 days is > 10000 mg/kg.

Based on the result of this study Hostavin 3206 is not subject for labelling and classification requirements according to regulatory requirements.