Anthemis Nobilis Flower Oil

Acute Toxicity: oral

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

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

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

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

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

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.