Registration Dossier

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
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 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 and 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 and were observed from hour 1 through to study day 1 after administration.
Body weight:
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.
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.