Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
mezcla de terpenos procedentes de la rectificación del Dihidromircenol.
EC Number:
947-968-9
Molecular formula:
C10H18
IUPAC Name:
mezcla de terpenos procedentes de la rectificación del Dihidromircenol.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
6 to 7 weeks old

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
single dose at 2000mg/kg
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured
Clinical signs:
No abnormalities observed
Body weight:
Body weight changes within the expected range

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met