Registration Dossier

Administrative data

Description of key information

The acute oral and dermal toxicity of Anthemis nobilis, ext. (Chamomile oil), was evaluated using 10 rats and 4 rabbits, respectively (strains and sex unspecified). The animals were administered a single dose of 5 g/kg bw, and were then observed for 14 days. There were no mortalities. The acute oral and dermal LD50 was reported to be > 5 g/kg bw (Johnson et al., 2017).

No relevant acute inhalation toxicity data were identified, or are needed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
not specified
Sex:
not specified
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.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0/10
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Remarks:
Testing carried out in 1973; predates GLP
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Doses:
5 g/kg bw
No. of animals per sex per dose:
4 animals in total [sex unspecified]
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0/4
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 of Anthemis nobilis, ext., (Chamomile oil) in rabbits was > 5 g/kg bw.
Executive summary:

The acute dermal toxicity of Anthemis nobilis, ext. (Chamomile oil), was evaluated using 4 rabbits [unspecified strain; unspecified sex ratio]. The rabbits were administered a single dose of 5 g/kg bw, and were then observed for 14 days. There were no mortalities. The dermal LD50 was reported to be > 5 g/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

Justification for classification or non-classification

Based on the results of the available and reliable acute oral rat and acute dermal rabbit studies (Johnson et al., 2017), Anthemic nobilis ext., (Chamomile oil) does not require classification according to EU CLP criteria (EC 1272/2008).