Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Safety Assessment of Anthemis nobilis– Derived Ingredients as Used in Cosmetics
Author:
Johnson W, Heldreth B, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW and Andersen FA
Year:
2017
Bibliographic source:
International Journal of Toxicology 36(Supp. 1), 57S-66S.
Reference Type:
publication
Title:
Monographs on fragrance raw materials: Chamomile oil Roman.
Author:
Opdyke DLJ
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology 12, 853.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Testing carried out in 1973; predates GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
None given

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5 g/kg bw
No. of animals per sex per dose:
10 animals in total [sex not specified]
Control animals:
not specified
Details on study design:
Administration was followed by a 14-day observation period.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0/10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of Anthemis nobilis, ext., (Chamomile extract) in rats was > 5 g/kg bw.
Executive summary:

The acute oral toxicity of Anthemis nobilis, ext. (Chamomile oil), was evaluated using 10 rats [unspecified strain; unspecified sex ratio]. The rats were administered a single dose of 5 g/kg bw, and were then observed for 14 days. There were no mortalities. The LD50 was reported to be > 5 g/kg bw.