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:
2007
Report Date:
2007

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

Test animals

Species:
rat
Strain:
other: Crl:(WI)BR
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
2000 mg/kg b.w.: all animals died on the day of the administration
Gross pathology:
An abnormal finding, namely a systolic heart arrest, was present only in deceased animals (2000 mg/kg bw).
All other animals were normal at the necropsy 14 d.
Other findings:
All animals were affected after administation.
The findings, with an onset shortly after the administration and lasting until death or to a
maximum of 6 h were:
Central nervous effects: clonic convulsions. Signs of reduced well-being. This term encompasses unspecific alterations, like sedation,
apathy, piloerection, hunched posture or closed eyes, in single or multiple occurrence.

Applicant's summary and conclusion

Conclusions:
According to the GHS (Globally Harmonised System) the test substance "rac-1-(3-Methoxyphenyl)ethylamine" should be classified in the hazard category 4 (LD50 value in the range of 300 - 2000 mg per kg body weight).