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
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

Constituent 1
Chemical structure
Reference substance name:
2-methylpentyl 2-methylisocrotonate
EC Number:
280-815-8
EC Name:
2-methylpentyl 2-methylisocrotonate
Cas Number:
83783-81-7
Molecular formula:
C11H20O2
IUPAC Name:
2-methylpentyl 2-methylbut-2-enoate
Constituent 2
Chemical structure
Reference substance name:
2-methylallyl 2-methylisocrotonate
EC Number:
262-901-7
EC Name:
2-methylallyl 2-methylisocrotonate
Cas Number:
61692-78-2
Molecular formula:
C9H14O2
IUPAC Name:
2-methylprop-2-en-1-yl 2-methylbut-2-enoate
Constituent 3
Chemical structure
Reference substance name:
Isobutyl isobutyrate
EC Number:
202-612-5
EC Name:
Isobutyl isobutyrate
Cas Number:
97-85-8
Molecular formula:
C8H16O2
IUPAC Name:
isobutyl 2-methylpropanoate
Constituent 4
Chemical structure
Reference substance name:
6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
EC Number:
227-705-8
EC Name:
6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
Cas Number:
5947-36-4
Molecular formula:
C10H16O
IUPAC Name:
6,6-dimethyl-2-methylenebicyclo[3.1.1]heptan-3-ol
Constituent 5
Chemical structure
Reference substance name:
Pin-2(3)-ene
EC Number:
201-291-9
EC Name:
Pin-2(3)-ene
Cas Number:
80-56-8
Molecular formula:
C10H16
IUPAC Name:
2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
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.