Registration Dossier

Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
226 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The results for fertility toxicity in an OECD Toolbox v3.4 study according to the TG422 protocol was NOEL (rat,oral,45d) 226 mg/kg bw/day

Note that the OECD SIDS for 2,2,6,6-tetramethylpiperidin-4-ol (EINECS 219-291-2), the analogue which is missing the methyl-group on the N, writes:

"In the above screening test [OECD TG 422], the substance was given from 14 days before

mating to 20 days after mating in males, and to day 3 of lactation in females. In the 600 mg/kg

group, the mean estrous cycle was prolonged with continuous diestrous in three females. With

regard to the effects on neonates, viability and body weight on day 4 of lactation were decreased

in the 600 mg/kg group. These effects are secondary non-specific consequence of systemic

toxicity. The NOEL for reproductive /developmental toxicity was considered to be 200

mg/kg/day".

Mentioned NOELs (rat, oral, gavage OECD TG422) are:

For reproductive toxicity

NOEL parental > 600 mg/kg/d (male)

NOEL parental 200 mg/kg/d (female)

NOEL F1 200 mg/kg/d

For teratogenicity

NOEL > 600 mg/kg/d

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

At the found effect level of NOEL=226 mg/kg/d according to the OECD TG422 protocol there is no requirement to classify this substance for this endpoint.

Additional information