Registration Dossier

Administrative data

Description of key information

Rat oral LD₅₀ 3810 mg/kg bw (non-guideline study); rat oral LD₅₀ ca. 5000 mg/kg bw (non-guideline study); rat oral LD₅₀ >2000 mg/kg bw (read across substance).  Rat dermal LD₅₀ > 5000 mg/kg bw (non-guideline study); rabbit dermal LD₅₀ > 5000 mg/kg bw (non-guideline study).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 810 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Regarding the afore mentioned results from dermal and oral studies, Cyclamen Aldehyde can be considered as not possessing acute toxicity via the routes represented in these studies.


Justification for selection of acute toxicity – oral endpoint
3x WoE all indicating LD50 >2000mg/kg which is above the highest CLP classification dose (2000mg/kg)

Justification for selection of acute toxicity – dermal endpoint
acute dermal LD₅₀ to rats of the test material was > 5000 mg/kg bw.

Justification for classification or non-classification

3x WoE all indicating LD50 >2000mg/kg

acute dermal LD₅₀ to rats of the test material was > 5000 mg/kg bw

These values are outside of the scope of CLP for classification as acutely toxic via the routes represented