bis(hydrogenated tallow C16-18-alkyl)hydroxylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-05-19 to 1995-07-05

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

31 July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

-

EC Number:

418-370-0

EC Name:

-

Cas Number:

143925-92-2

Molecular formula:

C32-36 H67-74 N1 O1

IUPAC Name:

N-hexadecyl-N-octadecylhydroxylamine

Test material form:

solid

Details on test material:

- State of aggregation: solid

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited; Animal Production; 4332 Stein / Switzerland
- Age at study initiation: young adult albino rats
- Weight at study initiation: 172 to 223 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: relative humidity of 55 ± 10 %.
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hour/day light cycle.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight

Doses:

2000 mg/kg bpody weight

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days; Signs and symptoms: daily for 14 days; Body weight: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes

Statistics:

NA

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:

No mortality occurred in this study.

Clinical signs:

other: Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application.

Gross pathology:

At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Upon single oral administration of 2000 mg/kg to male and female rats (Limit test) and a 14 day post-treatment observation period, an LD50 of greater than 2000 mg/kg was determined for the test item.

Executive summary:

In an oral toxicity study according to OECD guideline 401, 5 rats per sex were dosed once with the test article in arachis oil by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortalities were recorded. Piloerection and hunched posture were considered unspecific signs of distress (application) in acute tests. All animals recovered within 2 days after application. Body weight was not affected by the treatment. At necropsy, 4 of 5 males had a mottled thymus. No other deviations from normal morphology were found. The oral LD50 value of the test article in rats was established to exceed 2000 mg/kg body weight.