Registration Dossier

Administrative data

Description of key information

The submission substance is considered not classified with regards to skin irritation/corrosion. 
The test material produced irreversible effects and was considered to be corrosive to the rabbit eye.
The test material was also considered to be irritant according to EU labelling regulations Commission Directive 93/21/EEC. It is reasonable to assume that the symbol "Xi", the indication of danger "Irritant" and the highest risk phrase R 41 "RISK OF SERIOUS DAMAGE TO EYES" are therefore required. Under the GHS it is classified under the health hazard category : "Eye Damge 1" with a hazard statement H318: Causes serious eye damage.

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)

Additional information

Skin Irritation/corrosion.

The objective of this study was to assess the relative level of primary dermal skin irritation of a test material on rabbits under semioccluded conditions. The study was conducted according to EPA guidelines: EPA OTS 798.4470 (Acute Dermal Irritation)

The primary dermal irritation potential of N-(n-butyl) thiophosphoric triamide (NBPT) was evaluated in rabbits under 4-hour semioccluded conditions. The test material produced only a very slight erythema reaction in one animal. No other dermal irritation was observed The average of the 4-, 24-, 48- and 72-hour index scores is 0.04 (considered to be slightly irritating). All irritation cleared by the 48-hour observation.

The submission substance is considered not classified with regards to skin irritation/corrosion.

Eye Irritation

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

-OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987)

-Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

The test material produced irreversible effects and was considered to be corrosive to the rabbit eye.

The test material was also considered to be irritant according to EU labelling regulations Commission Directive 93/21/EEC. It is reasonable to assume that the symbol "Xi", the indication of danger "Irritant" and the highest risk phrase R 41 "RISK OF SERIOUS DAMAGE TO EYES" are therefore required. Under the GHS it is classified under the health hazard category "Eye Damge 1" with a hazard statementH318: Causes serious eye damage.


Effects on eye irritation: highly corrosive

Justification for classification or non-classification

The submission substance is considered not classified with regards to skin irritation/corrosion.

The test material produced irreversible effects and was considered to be corrosive to the rabbit eye.

The test material was also considered to be irritant according to EU labelling regulations Commission Directive 93/21/EEC. It is reasonable to assume that the symbol "Xi", the indication of danger "Irritant" and the highest risk phrase R 41 "RISK OF SERIOUS DAMAGE TO EYES" are therefore required. Under the GHS it is classified under the health hazard category "Eye Damge 1" with a hazard statement H318: Causes serious eye damage.