Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

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:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
4-allylanisole
EC Number:
205-427-8
EC Name:
4-allylanisole
Cas Number:
140-67-0
Molecular formula:
C10H12O
IUPAC Name:
1-methoxy-4-(prop-2-en-1-yl)benzene
Specific details on test material used for the study:
Purity: 99.53 %
Appearance; Clear, liquid
Storage Room temperature (20 ± 5°C); keep away of light

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
300 mg/kg body weight
2000 mg/kg body weight
No. of animals per sex per dose:
6

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Mortality:
Mortality of 3/6 females at limit dose of 2000 mg/kg body weight was noted. All 6/6 females
survived the dose of 300 mg/kg body weight.
Clinical signs:
Test item-related mortality in females treated with the test item in dose of 2000 mg/kg body weight
was not observed during the 48 hours. Lethargy was observed in 2 animals (No 2, 6) between 0.5-1
hour post-treatment. Toxicity sings as piloerection (animals No 1, 3, 6) and eye discharge (animal
No 6) were observed from Day 8 to Day 10.
On Day 10 post-treatment animals No 1, 4 and 6 were found dead. Animals died probably during
the night hours, because cadavers were in a state of autolysis.
No mortality was observed in females treated with the test item at dose of 300 mg/kg body weight.
During the follow up period, no animals displayed signs of intoxication, change of health, nor any
other adverse reaction negative reactions.
Body weight:
The body weight of all animals treated with the dose of 2000 mg/kg decreased during week 1. No
body weight losses of the surviving animals between first and second week after administration
were observed.
Body weight in animals (except one female) treated with the dose of 300 mg/kg was increased
between first and second week after administration.
Gross pathology:
Animals No 4 and 6 (dose 2000 mg/kg) could not be necropsied because cadavers were autolysed.
Gastric erosions, petechial haemorrhages on the gastric mucosa, splenomegaly, hepatomegaly,
diffuse scattered formations extending above the hepatic parenchyma and hepatic steatosis were
registered in animals surviving the 14-day observation period.
All animals treated with dose of 300 mg/kg body weight were necropsied. During necropsy, no
macroscopic findings were noticed

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 of the test item Estragole is higher than 300 mg/kg body weight and lower than 2000
mg/kg body weight after single oral administration to Wistar rats.