Registration Dossier

Administrative data

Description of key information

Three rabbits were exposed for 4 hours to 0.5g of undiluted PTH-decahydroamide.  The dermal test sites showed no signs of irritation (based on Draize assessments of erythema and oedema) at any of the scoring timepoints.
Three rabbits had PTH-decahydroamide instilled into one eye (81 mg, the weight equivalent to a volume of 0.1 ml). Iridial and corneal responses were generally slight and transient but more marked conjunctival changes, particularly in two animals, indicated a degree of ocular irritation that was persistent and exceeded the classification threshold values for application of the Risk Phrase R36 and classification according to Commission Regulation (EC) No. 1272/2008 requires the Signal word "Warning", appropriate GHS pictogram and classification "Category 2: Eye irritant with the hazard statement 'H319: causes serious eye irritation'

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

Three rabbits were exposed to PTH-decahydroamide for four hours under a semi-occlusive dressing. The treated sites were assessed for signs of dermal irritation at 24, 48 and 72 hours after dosing and again 7 days after treatment. No evidence of dermal irritation (erythema, oedema or other dermal reactions) was observed at any point during the study.

No classification is required for skin irritation potential of PTH-decahydroamide.

The irritation potential to rabbit eye of Ro 31 -9373 (PTH-decahydroamide) was investigated using a standard protocol based on OECD Test Guideline 405. Ro 31 -9373 (PTH-decahydroamide) was instilled into the conjunctival sac of three New Zealand White rabbits, as 81 mg of powder (weight equivalent to the volume of 0.1 ml). The eyes were examined at 1, 24, 48 and 72 hours after dosing and then on day 7, and reactions scored using the standard Draize assessment method. Corneal opacity generally resolved by Day 3 having been noted in two of the treated eyes. Iritis, also noted in two animals was slight in degree but persisted through the 72 hour assessment and had resolved by Day 7. Conjunctival irritation, redness and swelling, was observed in all three treated eyes but was only moderate or marked in two animals. The degree of response in these two rabbits was sufficient to require classification as R36, Irritating to eyes, according to the DSD.

Classification according to Commission Regulation (EC) No. 1272/2008 requires the Signal word "Warning", appropriate GHS pictogram and classification as "Category 2: Eye irritant with the hazard statement 'H319: causes serious eye irritation'.

Precautionary statements P264 and P280 for prevention and P305 +P351 +P338 and P337 +P313 for response should be considered.


Effects on eye irritation: irritating

Justification for classification or non-classification

No classification is required for skin irritation potential of PTH-decahydroamide, since no dermal reactions were elicited in a guideline compliant three rabbit in vivo study.

The slight to moderate reactions observed in two of the three rabbit eyes were sufficient to classifiy the test substance on the basis of persistent moderate chemosis. The Risk phrase R36, Irritating to eyes is required together with the Xi hazard warning and appropriate coding for CLP (GHS) classificaton system.

Classification according to Commission Regulation (EC) No. 1272/2008 requires the Signal word "Warning", appropriate GHS pictogram and classification "Category 2: Eye irritant with the hazard statement 'H319: causes serious eye irritation'