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EC number: 219-291-2 | CAS number: 2403-88-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline compliant
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
- Reference Type:
- secondary source
- Title:
- SIDS DOSSIER: 2,2,6,6-Tetramethylpiperidin-4-ol, CAS-No: 2403-88-5
- Author:
- OECD SIDS
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Remarks:
- Biosafety Research Center, Food, Drugs and Pesticides (An-Pyo Center), Japan
- Limit test:
- no
Test material
- Reference substance name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- EC Number:
- 219-291-2
- EC Name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- Cas Number:
- 2403-88-5
- Molecular formula:
- C9H19NO
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-ol
- Details on test material:
- - Name of test material (as cited in study report): 2,2,6,6-Tetramethylpiperidin-4-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks old for female and male animals
- Weight at study initiation: 359 - 400g for males; 227 - 282g for females
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: at the most 3 days, until proof of pregnancy
- Proof of pregnancy: vaginal plug / sperm in vaginal smear - Duration of treatment / exposure:
- Male: for 48 days from 2 weeks prior to mating
Female: for 41-52 days from 2 weeks prior to mating to day 3 postpartum throughout mating and pregnancy - Frequency of treatment:
- once daily
- Duration of test:
- Male: for 49 days
Female: for 42-53 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 60, 200, 600 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once a day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once a day
BODY WEIGHT: Yes
- Time schedule for examinations: for males: once a week, the first and the last day of the administration, the sacrificed day; for pregnant females: on day 0, 14 and 20 of gestation, on day 0 and 4 of lactation
FOOD CONSUMPTION: Yes
- Time schedule: once a week, on the same day when body wt. determined
CAGE SIDE OBSERVATIONS: Yes / No / No data
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes / No / No data
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes / No / No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on lactation day 4
- Organs examined: all organs which might be expected to have histopathological changes at the higher dose
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No
- Number of late resorptions: No - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No
- Skeletal examinations: Yes: all per litter (macroscopic examination)
- Head examinations: Yes: all per litter (macroscopic examination) - Statistics:
- Dunnett's or Scheffe's test for continuous data and Chi square test for quantal data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Body weight gain was decreased at more than 200 mg/kg/day. In clinical signs, blepharoptosis and mydriasis were observed in all groups, and their changes were dose-related. In 60 mg/kg/day group, the incidence for mydriasis was low and was observed concurrently with blepharoptosis at a slight degree and only sporadically. Mortality occurred in one female at 60 mg/kg/day, and one female at 600 mg/kg/day. At 600 mg/kg/day, the discontinued rats revealed reddish spots in digestive tracts, abnormal foci with gastric ulcer and the vacuolar degeneration in renal tubular epithelium. On the basis of clinical signs, a NOAEL of less than 60 mg/kg/day was set under the conditions of the study.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- < 60 mg/kg bw/day (nominal)
- Basis for effect level:
- clinical signs
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: pups of the 600mg/kg group showed lower body weight on day 4 of lactation
Details on embryotoxic / teratogenic effects:
With regard to the effects on neonates, viability on day 4 of lactation was decreased in the 600 mg/kg group, and male and female pups of the 600 mg/kg group showed lower body weights on day 4 of lactation. There are no significant differences in the delivery index and live birth index. Also, no exteral and visceral abnormalities related to the test substance were detected in any of the offspring.
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Litter results of rats treated orally with 2,2,6,6 -Tetramethylpiperidin-4 -ol:
Dose level (mg/kg/day) | 0 | 60 | 200 | 600 |
No. of pups born | 16.3±2.0 | 15.3±3.3 | 15.4±1.5 | 15.7±2.7 |
Delivery index (%) | 92.9±7.0 | 90.3±16.2 | 85.2±6.9 | 92.1±6.0 |
No. of pups alive on day 0 of lactation | ||||
Total | 16.3±2.0 | 15.2±3.3 | 15.3±1.4 | 15.7±2.7 |
Male | 8.2±2.2 | 7.7±2.3 | 7.9±1.8 | 7.0±3.0 |
Female | 8.2±1.5 | 7.5±2.6 | 7.4±2.2 | 8.7±2.3 |
Live birth index (%) | 100±0.0 | 99.5±1.8 | 99.5±1.7 | 100±0.0 |
Sex ratio (Male/Female) | 1.05±0.37 | 1.15±0.46 | 1.22±0.60 | 0.90±0.57 |
No. of pups alive on day 4 of lactation | ||||
Total | ||||
Male | 7.8±2.0 | 7.5±2.2 | 6.5±2.7 | 4.3±2.9 |
Female | 7.4±1.1 | 6.5±2.5 | 6.3±2.5 | 6.4±3.7 |
Viability index (%) | ||||
Total | 96.1±7.5 | 96.8±5.4 | 82.7±28.4 | 67.2±39.2 |
Male | 91.9±9.9 | 86.2±10.4 | 85.8±20.3 | 70.7±35.0 |
No. Of total dead pups born (mean±S.D.) | 0.0±0.0 | 0.1±0.3 | 0.1±0.3 | 0.0±0.0 |
Stillbirth | 0.0±0.0 | 0.0±0.0 | 0.0±0.0 | 0.0±0.0 |
cannibalism | 0.0±0.0 | 0.1±0.3 | 0.1±0.3 | 0.0±0.0 |
Delivery index (%) = (No. of pups born/No. of implantation sites) x 100
Live birth index (%) = (No. of live pups on day 0/No. of pups born) x 100
Viability index (%) = (No. of live pups on day 4/No. of live pups on day 0) x 100
Sex ratio = Total No. of male pups/ Total No. of female pups
Values are expressed as Mean±S.D. except sex ratio
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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