Registration Dossier

Administrative data

Description of key information

Two skin sensitisation studies (Maximization test in guinea pigs) have been conducted on the substance. Both studies showed the substance to be non-sensitising to skin.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Two skin sensitisation studies (Arcelin G (2011) and Manciaux X (2002d)) were conducted (Maximisation method, OECD Guideline no.406) on the substance (Polyphosphoric acids, esters with triethanolamine, sodium salts). Both studies are considered to be of reliability 1 and are summarised below:

Arcelin G (2011) - Key Study

In order to assess the cutaneous allergenic potential of Polyphosphoric acids, esters with triethanolamine, sodium salts, the Maximization-Test was performed in 15 (10 test and 5 control) male albino Dunkin Hartley guinea pigs, in accordance with OECD Guideline No. 406 and the Commission Regulation (EC) No 440/2008, B.6.

The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 10% dilution of the test item in purified water and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitisation was conducted for 48 hours under occlusion with the test item at 100% (neat, applied as delivered) one week after the intradermal induction. The animals of the control group were intradermally induced with purified water and FCA/physiological saline,

Two weeks after epidermal induction the test and control animals were challenged by epidermal application of the test item at 75% in purified water and purified water alone under occlusive dressing.

Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

No intercurrent deaths occurred during the course of the study.

No toxic signs were evident in the guinea pigs of the control or test group.

No local skin effects were observed in the guinea pigs of the control or test group.

Manciaux X (2002d) - Supporting study

The sensitisation potential of RHODAFAC BP10 was evaluated in female Hartley guinea pigs according to the maximisation method of Magnusson and Kligman, described in O.E.C.D. guideline Nb.406, and in compliance with Good Laboratory Practice.

Concentrations of the test substance to be used in the main study were determined in a preliminary assay with 2 animals. Ten test and five control animals were then included in the main assay. In the main assay, the induction treatment consisted of 3 pairs of intradermal injections (0.1 ml) on day 1in the scapular area of the back: the test article at 10% (w/w) in the mixture Freund's complete adjuvant/isotonic saline, the test item in the vehicle, or the Freund’s complete adjuvant at 50% (v/v). Control animals received intradermal injections of saline, Freund's Complete Adjuvant, and vehicle at 50% (w/v) in a mixture Freund's Complete Adjuvant/0.9% NaCl.

On day 7, the same region received a topical application of sodium lauryl sulfate in vaseline (10% w/w) in order to induce local irritation. On day 8, the test article, undiluted, (treated group) or the vehicle (control group) was applied topically to the test site, which was then covered by an occlusive dressing for 48 hours.

On day 22, the animals of treated and control groups were challenged by a topical occlusive application of the vehicle and the undiluted test article for 24 hours on one flank. The cutaneous reactions were evaluated 24 and 48 hours after patch removal.

 

No clinical signs and no deaths were noted during the study.

No cutaneous reactions were observed after the challenge application.

 

Under these experimental conditions,RHODAFAC BP10 does not induce sensitisation response in guinea pigs.


Migrated from Short description of key information:
Two skin sensitisation studies (Maximization test in guinea pigs) have been conducted on the substance. Both studies showed the substance to be non-sensitising to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the above mentioned findings in two adjuvant sensitisation tests (M&K-test) in guinea pigs and in accordance to Regulation (EC) No 1272/2008, the substance (Polyphosphoric acids, esters with triethanolamine, sodium saltdoes not have to be classified and labeled as a skin sensitizer