1-Naphthalenemethanamine, N-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-methyl-, hydrochloride (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1.4. - 15.4.1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Study was performed before GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[(2E)-6,6,-Dimethylhept-2-en-4-yn-1-yl](methyl)(naphthalen-1-ylmethyl)amine hydrochloride

EC Number:

616-640-4

Cas Number:

78628-80-5

Molecular formula:

C21H26Cl1N1

IUPAC Name:

[(2E)-6,6,-Dimethylhept-2-en-4-yn-1-yl](methyl)(naphthalen-1-ylmethyl)amine hydrochloride

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld, Germany
- Weight at study initiation: 235 - 279 g (males), 187 - 212 g (females)
- Fasting period before study: Animals were fasted about 18 h prior to administration.
- Housing: Animals were housed in groups of five in Wire IV cages.
- Diet: SFI Rats and Mice standard feed (pellets), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 - 24.5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 01.04.1981
To: 15.04.1981

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: as 20% emulsion in a 2% aqueous Tween 80 solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 and 20% (w/v)

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

2000 and 4000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed continuously until 5 h after dosing and then at least twice daily over a period of two weeks. Body weights were recorded prior to application and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Clinical signs observed were apathia (3/10 males, 2/10 females), stupor (3/10 males, 2/10 females), comatose state (1/10 males), ataxia (2/10 males), flaccid paresis (1/10 males), lateral position (1/10 males), chromodacryorrhoea (2/10 males), ptosis (1/1

Gross pathology:

In 5 animals, hyperplasia of Peyer's patches was observed in 1/5 males and 3/5 females at 2000 mg/kg bw and in 1/5 males at 4000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified