Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 August 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
no guideline followed
Principles of method if other than guideline:
In a laboratory environment at 20 deg C the following was carried out:
1) 100g of oil was shaken with 100g of double distilled water in a 250 ml separating flask and left for 2 hours. Then in a fume cupboard the bottom layer (Water) was drawn off and shaken with 100g of Dichloromethane in a further 250 ml separating flask. After leaving for 2 hours the bottom layer of Dichloromethane was examined by GC for the presence of Chamomile oil.

2) 100g of Chamomile oil was shaken with 100g of Dichloromethane and 100g of double distilled water, left for 2 hours and the bottom layer of DCM and Chamomile examined by GC

3) The GC method was by external standardization using a HP5 column under temperature programmed conditions. A fixed amount (0.5 microlitre diluted at 10%) of the two samples prepared as described above were run under the same conditions and the total GC area counts of the Chamomile components compared.
The whole experiment was repeated 5 times to obtain an average result.

NB The extraction efficiency of the Dichloromethane was tested using standard solutions of Chamomile in water and found to be in excess of 90%.
GLP compliance:
no
Type of method:
flask method
Key result
Water solubility:
110 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
7
Conclusions:
The solubility of Anthemis nobilis, ext., (Chamomile oil) in water was 110 mg/L.
Executive summary:

The aqueous solubility of Anthemis nobilis, ext., (Chamomile oil) was determined to be 110 mg/L at 20 deg C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion