1-Naphthalenamine, 1,2,3,4-tetrahydro-, (1S)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study conducted according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,4-tetrahydro-1-naphthylamine

EC Number:

218-712-7

EC Name:

1,2,3,4-tetrahydro-1-naphthylamine

Cas Number:

2217-40-5

IUPAC Name:

1,2,3,4-tetrahydronaphthalen-1-amine

Details on test material:

Name of test substance: 1-Aminotetralin
Test substance No.: 05/0560-1
Batch Identification: 7346-05/67 Hauptlauf
Purity: 98.2 area%
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

300, 500 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

300 - 500 mg/kg bw

Mortality:

Two animals of the 500 mg/kg administration group were found dead within 4 hours after application.
No mortality occurred in the 300 mg/kg administration groups.

Clinical signs:

other: Clinical observation in one animal of the 500 mg/kg administration group revealed poor general state, dyspnoea, lateral position, clonic convulsions and salivation and were observed from hour 1 through to hour 3 after administration. No clinical signs and

Gross pathology:

The following macroscopic pathologic finding was observed in one animal that died (500 mg/kg: 1 female): red erosion/ulcer, in the glandular stomach, diameter 3 mm. No macroscopic pathologic abnormalities were noted in the other animal that died (500 mg/kg: 1 female) and in the animals examined at the end of the observation period (500 mg/kg: 1 female; 300 mg/kg: 6 females).

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose of 1-Aminotetralin after oral administration was found to be greater than 300 mg/kg and less than 500 mg/kg body weight in rats.

Executive summary:

The study was performed to assess the acute toxicity following oral administration of 1-Aminotetralin in Wistar rats. Single doses of 500 and 300 mg/kg body weight of test material preparations in olive oil Ph.Eur./DAB were given to three administration groups of three fasted female animals, each, (500 mg/kg in 3 females, 300 mg/kg in 6 females) by gavage in a sequential manner. Two animals of the 500 mg/kg administration group were found dead within 4 hours after application. No mortality occurred in the 300 mg/kg administration groups. Clinical observation in one animal of the 500 mg/kg administration group revealed poor general state, dyspnoea, lateral position, clonic convulsions and salivation. Findings were observed from hour 1 through to hour 3 after administration. No clinical signs and findings were observed in another animal of the 500 mg/kg administration group that died because lethality occurred immediately after administration. In addition no clinical signs and findings were observed in the surviving animal of the 500 mg/kg administration group. Clinical observation in the first 300 mg/kg administration group revealed impaired or poor general state, dyspnoea, lateral position, staggering, ataxia, rolling or clonic convulsions and smeared fur. Findings were observed from hour 0 through to study day 2 after administration. Clinical observation in the second 300 mg/kg administration group revealed impaired general state, dyspnoea and piloerection. Findings were observed from hour 1 through to study day 1 after administration. The body weight of the surviving animal of the 500 mg/kg administration group increased during the first post exposure observation week but did not adequately increase during the second week. The mean body weights of the 300 mg/kg administration groups increased throughout the study period. During necropsy one animal that died in the 500 mg/kg administration group showed red erosion/ulcer in the glandular stomach. No macroscopic pathologic abnormalities were noted in the other animal that died (500 mg/kg: 1 female) and in the animals examined at the end of the observation period (500 mg/kg: 1 female; 300 mg/kg: 6 females). Under the conditions of this study the median lethal dose of 1-Aminotetralin after oral administration was found to be greater than 300 mg/kg and less than 500 mg/kg body weight in rats.