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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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:
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): TK 11725/1, HTMP
- Physical state: solid, white

- Lot/batch No.: HT-92-034
- 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
- Weight at study initiation: 219 to 252 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- % coverage: at least 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): 4 ml/kg
- Constant volume or concentration used: no

Duration of exposure:
24 hours
Doses:
2000 mg/kg
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: observations: daily; weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Lichtfield-Wilcoxon method

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities occurred in this study.
Clinical signs:
other: Piloerection and hunched posture were seen, which are considered as common and unspecific symptoms in acute dermal tests due to treatment. At the application site erythema were seen in all animals. Necrosis was observed in one male and one female. The ani
Gross pathology:
At necropsy, no abnormalities were found.

Applicant's summary and conclusion