Registration Dossier

Administrative data

Description of key information

In vivo skin irritation:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the US EPA Guideline - OPPTS 870.2500 "Acute Dermal Irritation". A single 4-hour, semi-occluded application of the test material to the shaved intact skin of three rabbits produced very slight erythema and very slight oedema (score 1) after 24 hours. The effects were fully reversible within 48 hours. Therefore the test item is considered as non irritant to the skin.
In vivo eye irritation:
The acutc eye irritation/corrosion of a liquid Quillaja saponaria extract was tested in three albino rabbits according to US EPA Guideline EPA OPPTS 870.2400 . The test item was instilled as the original substance at a single dose of 0.1 ml to one of the eyes in each animal. The untreated eye was used as control.
The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48, 72 hours, 7 days and 14 days after instillation of the test item. The grades for ocular lesions were recorded in accordance with the Guideline.
Well defined signs of irritation were observed on the treated eyes. All effects were fully reversible within 14 days.
None of the animals died or showed clinical signs during the course of testing.
Based on the respective mean scores classification of the test item as causing serious eye irritation (Cat. 2) is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study 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 skin irritation / corrosion endpoint:
The key study is GLP compliant and reliable without restrictions.

Justification for selection of eye irritation endpoint:
The key study is GLP compliant and reliable without restrictions.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

A single 4-hour, semi-occluded application of the test material to the shaved intact skin of three rabbits produced very slight erythema and very slight oedema (score 1) after 24 hours. The effects were fully reversible within 48 hours.

According to CLP; EU GHS (Regulation (EC) No 1272/2008) no classification is required for skin irritation.

 

Eye irritation:

The acutc eye irritation/corrosion of a liquid Quillaja saponaria extract was tested in three albino rabbits according to US EPA Guideline EPA OPPTS 870.2400 . Well defined signs of irritation were observed on the treated eyes. All effects were fully reversible within 14 days.

None of the animals died or showed clinical signs during the course of testing.

Based on the respective mean scores classification of the test item as causing serious eye irritation (Cat. 2) is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).