Registration Dossier

Administrative data

Description of key information

Acute Dermal Irritation/Corrosion: according to the key study which was an in vivo skin irritation test (EPA Guideline for registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals, Fed. Reg. 43:163, 37336-37402, 1978) the substance is not irritating.  Acute Eye Irritation: according to the key study which was in vivo eye irritation test (EPA Proposed Guideline (May 24, 1982, FR22405; EPA PR Notice 81-3, 1981; similar to OECD 405), the substance is to be considered not irritating to the eye. 

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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Dermal Irritation/Corrosion:

In the key study performed with Phosflex 72B, mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of 6 albino rabbits following a 24 hour exposure was noted. At the 72 hour observation irritation decreased and included mild erythema in one of the six rabbits (no 14 days observation period done for reversibility). In the five additionally available supporting Skin irritation/corrosion studies the test substance was also not irritating to the rabbit skin.

Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), the test substance does not have to be classified and has no obligatory labelling requirement for skin irritation.

Acute Eye Irritation:

In the key study, the test substance (Fyrquel LT) was found to be a non-irritant in the eyes of albino rabbits. This formulation produced no eye irritation in rabbits whose eyes were left unwashed or in rabbits whose eyes were washed 20-30 seconds after treatment. In three additional supporting Eye irritation studies the test substance was also found to be not irritating to the rabbit eye. In two other remaining Eye irritation studies interpretation of the result and classification of the test substance was not possible, since the scoring system used is unknown and the protocol is missing.

Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation.

There are no test results available to evaluate the potential of the substance to cause respiratory irritation, therefore no conclusion can be drawn for this endpoint.

Justification for classification or non-classification

All key in vivo studies indicate that the substance does not induce any significant irritation to the skin and eye. Therefore, it can be concluded that the substance is not irritating and therefore does not need to be classified as such according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC.