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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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