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Administrative data

Description of key information

Skin irritation: Two acute dermal irritation studies in rabbits have been conducted. Very slight erythema was observed in both studies and very slight oedema in one study. All effects were reversible and not sufficient for classification.
Eye irritation: Two acute eye irritation studies in rabbits have been conducted. Slight to moderate conjunctival irritation was observed in both studies. All effects were reversible and not sufficient for classification.

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

Skin irritation:

Two dermal irritation studies (Sanders A (2011c) and Manciaux X (2002b)) were conducted (according to OECD guideline 404)

on the substance (Polyphosphoric acids, esters with triethanolamine, sodium salts). Both studies are considered to be of reliability 1 and are summarised below:

 

Sanders A (2011c) - Key study

Introduction.

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

Results.

3-minute and 1-hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.

A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced very slight erythema and very slight oedema. One treated skin site appeared normal at the 48-Hour observation and two treated skin sites appeared normal at the 7-Day observation.

Conclusion.

The test item produced a primary irritation index of 0.7 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test item produced a maximum individual mean score of 1.0 and therefore did not meet the criteria for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals.

Manciaux X (2002b) - Supporting study

RHODAFAC BP10 was tested for acute dermal irritation in 3 male New Zealand White rabbits, according to O.E.C.D. guideline Nb.404/EC method B4, and in compliance with Good Laboratory Practice. The test article was applied as such on a gauze, in a single dermal dose of 0.5 ml, to a clipped area of the skin under a semi-occlusive dressing, first during 3 minutes and 4 hours to a single animal. Since the test item was not irritating, it was then applied during 4 hours to 2 other animals. The cutaneous examinations were performed 24, 48 and 72 hours after removal of the dressing.

 

No cutaneous reactions were observed after a 3-minute exposure. A very slight erythema (grade 1) was observed in one animal 1 hour after removal of the dressing, and on day 2. No cutaneous reactions were observed in the other animals. The mean scores (24-48-72 hours) calculated for each animal were 0.0 – 0.0 – 0.3 for erythema, and 0.0 – 0.0 – 0.0 for oedema.

 

Based on these results, RHODAFAC BP10 is not irritating to the skin, according to criteria of the Annex VI to Directive 67/548/EEC.

Eye Irritation:

Two eye irritation studies (Sanders A (2011d) and Manciaux X (2002c)) were conducted (according to OECD guideline 405)

on the substance (Polyphosphoric acids, esters with triethanolamine, sodium salts). Both studies are considered to be of reliability 1 and are summarised below:

Sanders A (2011d) - Key study

Introduction.

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.

Result.

A single application of the test item to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Two treated eyes appeared normal at the 48-Hour observation and the remaining treated eye appeared normal at the 72-Hour observation.

Conclusion.

The test item produced a maximum group mean score of 12.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test item does not meet the criteria for classification according to the Classification, Labelling and Packaging Regulation or the Globally Harmonised Classification System.

Manciaux X (2002c) - Supporting study

RHODAFAC BP10 was tested for acute ocular irritation on 3 male New-Zealand White rabbits, according to O.E.C.D. guideline Nb.405/EC method B5, and in compliance with Good Laboratory Practice. The test article was instillated as such, in a single dose of 0.1 ml, into the conjunctival sac of the left eye of each animal. The right eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed 1 hour, 24, 48 and 72 hours after the instillation.

 

Very slight conjunctival reactions (redness and chemosis) were observed at one hour in the treated eye of all three animals, and they persisted in one test animal until day 2 (24 hours after removal of the dressing). No other ocular reactions were recorded throughout the observation period. The mean scores (24-48-72 hours) calculated for each animal were 0.3 – 0.0 – 0.0 for conjunctival redness and 0.3 – 0.0 – 0.0 for chemosis, as well as for iritis and corneal opacity.

 

Based on these results, RHODAFAC BP10 is not classified as eye irritant according to criteria of the Annex VI to Directive 67/548/EEC.

Comments:

The substance tested in the key and supporting studies had different pH's:

Key studies:

Substance undiluted: pH 4.01

10% w/w aqueous preparation of the test item: pH 4.5

Supporting studies:

The pH of the test item at the concentration of 10% in water was 2 to 3,

It can be considered that although the substance can differ in pH, the pH does not significantly affect the substances potential to cause irritation. The substance tested with the lower pH in fact caused fractionally less irritation.Therefore it is considered that the substance will not be an irritant at any pH in the ranges tested.

Justification for classification or non-classification

The results from the skin and eye irritation studies were evaluated according to the Classification, Labelling and Packaging Regulation (CLP). The test item did not meet the criteria for classification for skin or eye irritation in any study.