2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 January 1999 - 28 January 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performend in a GLP laboratory in accordance with OECD guidelines. No deviations were noted.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

other: Solid

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride

EC Number:

246-014-2

EC Name:

2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride

Cas Number:

24085-08-3

Molecular formula:

C20H25NO3.HCl

IUPAC Name:

2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride

Test material form:

other: Orange solid

Details on test material:

Physical state: Orange solid

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:(WI) BR (outbred, SPF-Quality).

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: approx. 6 weeks old
- Weight at study initiation: Body weight variation did not exceed+/- 20% of the sex mean.
- Fasting period before study: Food was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet.
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg (10 ml/kg) body weight.
- Amount of vehicle (if gavage): (10 ml/kg) body weight.
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at NOTOX.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3 male and 3 female.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Two and four hours after treatment, subsequent daily observations were made until terminal sacrifice.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight and histopathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female died within 20 minutes post treatment. No further mortality occurred.

Clinical signs:

other: No clinical signs of systemic toxicity were noted in the females and lethargy was seen in all males on the day of treatment (day 1). A single observation of red staining of the head in one male was recorded on day 2.

Gross pathology:

Thickening and dark red discolouration of the limiting ridge in the stomach was found in the female that died on day 1. No abnormalities were found at macroscopic post mortem examination of the animals at scheduled sacrifice.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance does not have to be classified and has no obligatory labelling requirement for oral toxicity.

Executive summary:

The study was carried performed in a GLP laboratory and was based on the guidelines described in: EC Commission Directive 96/54/EC, Part 8.1 tris 'Acute Method' Toxicity-Oral, Acute Toxic Class Method' and OECD No.423, 'Acute Oral Toxicity - Acute Toxic Class Method'. No deviations were recorded.

the test substance was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (day 15).

The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results the test substance does not have to be classified and has no obligatory labelling requirement for oral toxicity.