Benzenemethanol, 3-hydroxy-.alpha.-[[methyl(phenylmethyl)amino]methyl]-, (.alpha.S)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol

Cas Number:

286426-31-1

Molecular formula:

C17 H20 O2

IUPAC Name:

3-[(1S)-2-[benzyl(methyl)amino]-1-hydroxyethyl]phenol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: solid
- Analytical purity: 99.7 %
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH , D-33178 Borchen
- Weight at study initiation: female 160 g -165 g and male 170 g- 180 g ( 3 female and 3 male animals were used )
- Fasting period before study: Animals were fasted by withholding food over night.
- Housing: The animals were individually kept in Macrolon cages on Altromin saw fiber bedding.
- Diet : Feeding ad libitium, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free-TPF
- Water : Free access to tap water ( drinking water, municipalresidue control, microbiol. controlled periodically )
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12:12, light 6.00-18.00

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 g
- Amount of vehicle (if gavage): 8 ml
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics

MAXIMUM DOSE VOLUME APPLIED: 2000mg/kg body weight

Doses:

2000 mg/kg body weigth;
Since no presence of compound-related mortality of the anmials was observed no further testing was required.

No. of animals per sex per dose:

3 male and 3 female animals per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals wer weighted prior to first application and once a week thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: A careful clinical examinationwas made twiche a day on the day of dosing and once day thereafter. Cageside
observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observation of tremor, convulsions,salivation,diarrhoea, lethargy,sleep and coma.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The oral application of the test item in a dose of 2000 mg/kg BW caused no compound related mortalities.
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: No clinical signs of toxicity were observed throughout the observation period.

Gross pathology:

Necropsy revelaed an acute injection of blood vessels in all animals in the abdominal region . This finding is due to euthanasia with an overdose of
pentobarbital injected intraperitoneally.
No other macroscopic necropsy findings were recorded.

Any other information on results incl. tables

Weight Gain

Animal Number / Sex	Day 0	Day 7	Day 14
1 male	170	202	237
2 male	178	200	245
3 male	180	203	242
1 female	160	172	188
2 female	162	173	187
3 female	165	182	196

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item L-Benzyladrianol Base has no acute toxic characteristics.
The LD50 was determined to be > 2000 mg/kg BW.

Executive summary:

The test item L-Benzyladrianol Base was given in a dose of 2000 mg/kg body weight to two groups of 3 male and 3 female rats

( HsdBrl: WH Wistar ) in a single exposure via oral gavage. A careful clinical examination was made once a day.

At the end of the observation period the animals were sacrified and necropsy was carried out to record gross pathological changes.

A maximum dosage of 2000 mg/kg BW according to the acute toxic class method regime, caused no compound related mortality

within 14 days p.appl.. No clinical signs of toxicity were observed throughout the oberservation period.