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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: The acute oral toxicity of the liquid QUILLAJA EXTRACT QL AGRI, LOTE: 260208-0700 was investigated according to US EPA Guideline EPA OPPTS 870.1100. A group of 3 female Sprague Dawley rats were administered a liquid extract of Quillaja saponaria at a single dose of 5000 mg/kg bw by gavage.
No mortality and no clinical signs of toxicity were obeserved. No abnormalities were recorded durcing necropsies. Therefore the acute oral LD50 value was estimated as > 5000 mg/kg bw.
Acute toxicity by the inhalation route: The acute toxicity by the the inhalation route of Quillaja saponaria powder was examined according to OECD Guideline 403. A limit test with an exposition of 0.45 mg/L as a nominal concentration was performed due to the physical-chemical properties of the test substance. This was the highest technical achievable concentration. A group of 5 males and 5 females received nasal only exposure to aerosol concentrations of the test substance during 4 hours. No mortality and clinical sign of toxicity were observed. No abnormalities were recorded during necropsy. Therefore the acute LC50 value of Quillaja saponaria powder can be stated as > 0.45 mg/l.
Acute dermal toxicity: The acute dermal toxicity of a liquid Quillaja saponaria extract was investigated according to US EPA Guideline EPA OPPTS 870.1200 (Acute Dermal Toxicity).
The test item was applied as a single dose of 2000 mg/kg bw to the shaved dorsal area of the trunk of 5 male and 5 female Sprague Dawley rats. The coverage of the exposed area was removed after 24 hours. No mortolatity or clinical signs of toxicity was observed. No abnormalites were recorded durcing necropsy. Therefore the acute dermal LD50 was estimated as > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
One reliable study is available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
450 mg/m³ air
Quality of whole database:
One reliable study is available.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
One reliable study is available.

Additional information

No data gaps were identified. The available data are adequate for risk assessment and classification and labelling purposes.


Justification for selection of acute toxicity – oral endpoint
The available study is GLP-compliant and therefore considered reliable without restrictions.

Justification for selection of acute toxicity – inhalation endpoint
The available study is GLP-compliant and therefore considered reliable without restrictions.

Justification for selection of acute toxicity – dermal endpoint
The available study is GLP-compliant and therefore considered reliable without restrictions.

Justification for classification or non-classification

Acute oral toxicity:

The respective criteria are not met.

The estimated LD50 of > 5000 mg/kg bw. is well above the treshold for hazard category 4 (2000 mg/kg bw). Quillaja saponaria ext. is therefore not classified for acute oral toxicity.

 

Acute toxicity via the the inhalation route:

The respective criteria are met. The estimated LC50 of > 0.45 mg/l as highest technical achievable concentration does not justify the classification of the test item.

 

Acute dermal toxicity:

The respective criteria are not met.

The estimated LD50 of > 2000 mg/kg bw. is above the treshold for hazard category 4 (2000 mg/kg bw). Quillaja saponaria ext. is therefore not classified for acute dermal toxicity.