Registration Dossier

Administrative data

Description of key information

Pyrochlore has been tested in one in vitro skin irritattion study (Commision regulation (EC) No. 440/2008 B.46) and one eye irritation study. All tests show a negative response, thus pyrochlore does not require classification either as skin or as eye irritant.

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 adverse effect observed (not irritating)

Additional information

One study has been performed on skin irritation (Jäger, 2010, Commision regulation (EC) No. 440/2008 B.46) and one study was performed on eye irritating properties (Leuschner, 2010, OECD guideline 405).

After treatment with the test item Pyrochlore the relative absorbance values were irrelevantly decreased to 92.5 %. this value is well above the threshold for irritacy of ≤ 50 %. Therefore, the test item is not considered to possess an irritant potential.

Under the present test conditions, a single instillation of 100 mg pyrochlore per animal into the conjunctival sac of the right eye of three rabbits caused the following changes: Conjunctival redness (grade 1: some blood vessels hyperaemic (injected)) was observed in all animals 1 hour after instillation. In addition, secretion was observed in one animal 1 hour after instillation. The corneae and the irises were not affected by instillation of the test item. The fluorescein test performed 24 hours after instillation did not reveal any changes. All effects observed were reversible within the first 21 days after application.

Justification for classification or non-classification

Skin irritation in vitro:

relative viability, mean, after 15 min incubation: score=92.5%

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item pyrochlore is non irritant to skin and therefore, the test item should not be classified and labeled as skin irritant according to regulation (EC) No.: 1272/2008. Also, the test item should not be classified and labeled as skin irritant according to Directive 67/548/EEC.

Eye irritation in vivo:

conjunctivae score, mean animal #1, 24 -72h: score=0            

conjunctivae score, mean animal #2, 24 -72h: score=0          

conjunctivae score, mean animal #3, 24 -72h: score=0          

cornea score, mean animal #1, 24 -72h: score=0

cornea score, mean animal #2, 24 -72h: score=0

cornea score, mean animal #3, 24 -72h: score=0

iris score, mean animal #1, 24 -72h: score=0

iris score, mean animal #2, 24 -72h: score=0

iris score, mean animal #3, 24 -72h: score=0

chemosis score, mean animal #1, 24 -72h; score=0

chemosis score, mean animal #2, 24 -72h; score=0

chemosis score, mean animal #3, 24 -72h; score=0

According to Directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and from the results obtained under the present test conditions, pyrochlore was non-irritating to the eyes, hence no classification and labelling is required. Also, according to the EC Regulation 1272/2008 and subsequent Regulations, the test item is considered to be non- irritating.

Respiratory irritation:

The classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) for further information.