Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable. Non-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
other: BASF-test
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Details on test material:
I- name of substance: homoveratrylamin
- Purity: 98 %
- substance number: 78/836
- appearance: clear, yellowish, slightly viscous liquid

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
- food: Herilan MRH-Haltung; H. Eggersmann KG

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
50 and 200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- fasting before application: 15-20 h
- observation period: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 160 mg/kg bw
Mortality:
Male animals:
- At the dose level of 200 mg/kg 1 animal was dead 2 days after administration and 4 had died after 14 days.
- At the lower dose level of 50 mg/kg no mortality was observed.

Female animals:
- At the dose level of 200 mg/kg 1 animal was dead 7 days after administration and 2 had died after 14 days.
- At the lower dose level of 50 mg/kg no mortality was observed.
Clinical signs:
Dyspnoea, apathy, spasms, ruffled fur, dehydration, bad general condition.
Body weight:
Mean body weigts [g] before administration/2-4 days after/ 7 days after/ 13 days after administration

Male animals
- 200 mg/kg bw dose level: 24/21.7/19.0/27.0
- 50 mg/kg bw dose level: 26/30.0/29.0/32.2

Female animals
- 200 mg/kg bw dose level: 20/19.0/18.7/21.0
- 50 mg/kg bw dose level: 22/25.2/25.6/27.4
Gross pathology:
The animals which had died during the course of the study showed no findings at necropsy. The animals which survived until the end of the study showed an astringent liver serosa at necropsy.

Applicant's summary and conclusion

Conclusions:
Based on the results of this study, an intraperitonealy administered dose of 50 mg/kg bw homoveratrylamin was well tolerated by the test animals, whereas administration of 200 mg/kg bw yielded clear signs of toxicity, resulting in mortality of 66.7 % of the testing animals.