Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
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:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
yes
Remarks:
5.1 mg/l (mean)
Duration of exposure:
ca. 4 h
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 5.1 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
0
Clinical signs:
Slight to moderate laboured and noisy respiration, sneezing, decreased activity, hunched posture and incoordination were noted for the exposed animals on day of exposure and/or several days after exposure. No abnormalities were detected in any animals from Day 6 of the observation period
Body weight:
Following exposure at 5.10 mg/L, slight to moderate body weight loss was observed in all animals on Day 1 which is associated with the restraint procedure during 4 hour exposure. Normal bodyweight gain was noted during the observation period for all female animals, the slight bodyweight loss was recorded during the first three days after exposure in males.
Other findings:
A single four hours nose-only exposure of E-Anethol to Wistar CRL: (WI) rats dosed at 5.10 mg/L followed by a 14 day of observation period, was not associated with any macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU