Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study (OECD).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Molecular formula:

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

IUPAC Name:

Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Details on test material:

- Name of test material (as cited in study report): DHW 80 50 %
- Physical state: pasty (at 20°C) and light yellow
- Composition of test material, percentage of components: 50 % active substance content
- Lot/batch No.: 59/0
- Stability under test conditions: stable for at least two years (pure); stable in aqua dest.
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, FRG
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: males 173 g and females 159 g average body weight
- Fasting period before study: 16 hours before dosage until 3 hours after gavage
- Housing: Makrolon Type-3 cages with standard softwood bedding, ARWI-Center, Essen, West Germany
- Diet: Pelleted Altromin Maintenance Diet 1324 (Fa. Altromin GmbH, 4937 Lage, West Germany), ad libitum
- Water: community tap water from Duesseldorf, ad libitum
- Acclimation period: 6 days under laboratory conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 ± 2°C
- Humidity (%): 45 % - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark

IN-LIFE DATES: From: 1990-11-13 To: 1990-11-27

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

2000 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 (or for the duration of toxic symptoms)
- Frequency of observations and weighing: Mortality/Viability symptoms were recorded at frequent intervals during test day one and two times a day during days 2-14, weighing was done 1 day before application, at day of application and on days 2, 7 and 14 after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology (macroscopic examination of the cranial, thoracic and visceral cavities)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

no mortality occured during the study period

Clinical signs:

other: all males and 4 females showed no clinical signs of toxicity up to the end of the 14-day observation period 1 female showed strong emaciation 7 days after application

Gross pathology:

male animals: no macroscopic findings considered to be treatment related
female animals: mild hydrometra (1 animal), spleen light-brown, light-yellow mucus in the urinary bladder, stasis of the urinary bladder (severe), pyelonephritis bilateral (1 animal), no abnormal findings in 3 animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance was >2000 mg/kg for male and female rats, according to "Off. J. Europ. commun., L 257, 1983, p. 18", the test substance has not been classified as acute harmful.