Aluminium fluoride

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitisation potential ofaluminum fluoridewas assessed in a GLP-compliant study performed according to OECD Guideline for the Testing of Chemicals No. 429 (local lymph node assay) (Beerens-Heijnen, 2010), which was selected as the key study. In the main study, groups of 5 female mice were tested with the diluted test material at concentrations of 50, 25, or 10% (w/w) in propylene glycol (vehicle). The mice were treated daily with an application of 25 µL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days. Another group of five mice received the vehicle alone in the same manner. Five days following the first topical application of the test material, all mice were injected via the tail vein with 250 µL of 3H-methyl thymidine (3HTdR). Five hours following the administration of 3HTdR, all mice were killed. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation. The incorporation of 3HTdR was counted by scintillation counter. Since treatment with the test material did not result in at least a 3-fold or greater increase in 3HTdR incorporation compared to control values, the test substance was considered to be non-sensitising under the conditions of the test. Slight irritation of the ears in animals treated at 50% was observed; the authors considered these as not a toxicologically significant effect on the activity of the nodes. The majority of auricular lymph nodes of experimental and control mice were considered normal in size, except for one node at 10% and one node at 25%, which were increased in size. The authors reported no macroscopic abnormalities of the surrounding area in any of the animals. Slight body weight loss were reported in some animals; however, the authors considered these as not toxicologically significant. In addition, no mortality occurred and no signs of systemic toxicity were reported. 

Therefore, no skin sensitisation potential is expected for aluminum fluoride.

Migrated from Short description of key information:
Aluminum fluoride was reported to be non-sensitising to skin in a local lymph node assay conducted in mice in a GLP-compliant study performed according to the OECD test guideline (No. 429).

Justification for classification or non-classification

There is no information available concerning respiratory sensitisation.

 

According to OECD TG 429 the submission substance is not a skin sensitizer. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.4.