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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Remarks:
Short-term Toxicology CIBA-GEIGY Limited
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol
EC Number:
258-132-1
EC Name:
4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol
Cas Number:
52722-86-8
Molecular formula:
C11H23NO2
IUPAC Name:
1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol
Details on test material:
- Physical state: solid; white
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif:RAI f1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: young adult
- Weight at study initiation: 219 to 254 g
- Fasting period before study: overnight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: about 10% of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
2000 mg/ml
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 14 days, weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
other: Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 1 day.
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Upon an acute dermal administration and a 14 day post-treatment observation period, an LD50 in rats of greater than 2000 mg/kg body weight was established.