Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: OECD Toolbox v3.4 read across study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,2,6,6-pentamethylpiperidin-4-ol
EC Number:
219-292-8
EC Name:
1,2,2,6,6-pentamethylpiperidin-4-ol
Cas Number:
2403-89-6
Molecular formula:
C10H21NO
IUPAC Name:
1,2,2,6,6-pentamethylpiperidin-4-ol

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
45d

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOEL
Effect level:
226 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: not specified
Remarks on result:
other: OECD TG422 protocol

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOEL
Generation:
F1
Effect level:
226 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no data
Remarks on result:
other: OECD TG422 protocol

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion