Phosphorous ester

Endpoint summary

Description of key information

The test item GARDO TP 10451 was investigated for skin irritation. The acute skin irritation study of GARDO TP10451 was performed in albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).

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

The acute skin irritation study of GARDO TP10451 was performed in albino New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002). The test item was administered undiluted, at a single dose of 0.5 mL. Gauze was placed onto the hairless skin of the rabbit, test item was applied to the gauze, additional gauze was placed over the test item and an adhesive clear plastic patch was applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control. After 4 hours, the remaining test item was removed with water of body temperature. To assess skin irritation, animals were examined at 1, 24, 48, 72 hours and 1 week after the patch removal. Additional general examinations were performed daily. There was no mortality or systemic clinical changes related to GARDO TP10451 administration. There was no effect of treatment on body weight. At observation one hour after patch removal, very slight erythema (score 1) was observed in two animals. At 24 and 48 hours after patch removal, very slight erythema (score 1) and very slight oedema (score 1) was noted in all animals. At 72 hours after patch removal, very slight erythema (score 1) was observed in all animals. At 1 week after patch removal, there were no observed signs noted on the skin of the treated animals. As no clinical signs were observed up to 1 week after patch removal, the study was terminated after the 1 week post-dosing observations. Under the conditions of this acute skin irritation/corrosion study with rabbits, the test item GARDO TP10451 did not cause any skin irritating effect.

Originally, an in-vitro study was planned to address this endpoint. But as rinsing (as described by the guideline) after exposure was found to be not possible because the substance is too viscous, the in-vivo study was performed.

Eye irritation

The in-vitro eye irritation study followed the procedures of the ICCVAM recommended protocol for the Bovine Corneal Opacity and Permeability (BCOP) test method. It was performed to assess the ocular irritancy potential of the test material to the isolated bovine cornea.  The undiluted test material was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control materials were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score. 

The in vitro irritancy score of the test material was 124.9 (equivalent to severe eye irritant) but found to be inconclusive. The test material was an extremely viscous liquid. At the end of the exposure period attempts to rinse the viscous test material from the eye were ineffective resulting in residual test material coating the cornea. Therefore, it was considered that the opacity and permeability readings were unreliable. Due to the extremely viscous physical state of the test material, the results of this study were considered inconclusive and, therefore, it was not possible to make a prediction of eye irritation.

As preliminary classification and for precautionary reasons, the substance is classified as irritating to the eyes (R36) until the results of an in vivo study are available.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Skin irritation:

According to directive 2001/59/EC, classification of Gardo TP10451as skin irritant is not required based on the results of this study.

Eye irritation:

Based on the (inconclusive) result of a BCOP test, as preliminary classification and for precautionary reasons, the substance is classified as irritating to the eyes (R36) until the results of an in vivo study are available.