Registration Dossier

Administrative data

Description of key information

Acute Dermal Irritation/Corrosion:
1) 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): not irritating.
2) In vivo skin irritation test (EPA Guideline Fed. Reg. 43:163, 37336-37402, 1978; similar to OECD 404): not irritating.
- Acute Eye Irritation:
1) In vivo eye irritation test (EPA Proposed Guideline (May 24, 1982, FR22405; EPA PR Notice 81-3, 1981; similar to OECD 405): not irritating.
2) In vivo eye irritation test (EPA Guideline for registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals, Fed. Reg. 43:163, 37336-37402, 1978; similar to OECD 405): not irritating.

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)

Additional information

Acute Dermal Irritation/Corrosion:

Key study 1) Phosflex 72B produced mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of 6 albino rabbits following a 24 hour exposure. 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).

Key study 2) At the 72 hour observation, 5 rabbits had mild to moderate erythema and irritation cleared in 1 rabbit. No 14 days observation period done for reversibility.

In the additional 4 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 both Key studies the test substance (Fyrquel LT and Phosflex 72B resp.) was a non-irritant in the eyes of albino rabbits. These formulations produced no eye irritation in rabbits whose eyes were left unwashed or in rabbits whose eyes were washed 20-30 seconds after treatment.

In 2 additional Supporting Eye irritation studies the test substance was also not irritating to the rabbit eye. In the other 2 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.

The respiratory irritation was not studied for BuTTP.

Justification for classification or non-classification

All key in vivo studies indicate that BuTPP 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.