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Diss Factsheets

Administrative data

Description of key information

skin: erythema score: 2.7 (not fully reversible within 14 days), edema score: 1.2; CIBA, 1992, GLP-OECD Guideline Study
eye: not tested because corrosive to skin

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Hüls AG, Marl, Germany
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
according to guideline
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g with 0.5 mL water to 6cm2
Duration of treatment / exposure:
animal 1: 4 hours, thereafter the bandage was removed and the site washed with water
animal 2: 3 min: open patch
animal 3: 1 hour: semiocculsive, observation up to 6 days
Observation period:
animal 1: up to 72 hours post application. Due to the high corrosvitiy, the animal was killed after 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gatze fixed with non irritating adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Guideline
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
4
Max. score:
4
Reversibility:
other: animal was killed after 3 days
Remarks on result:
other: 4 hour test
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
4
Max. score:
4
Reversibility:
other: animal was killed after 3 days
Remarks on result:
other: 4 hour test
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3 min test
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1 hour test
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1 hour test

1 hour exposure time: After 30 to 60 min and after 24 hours clear erythema and very slight edema were seen. After 48 and 72 hours only dry skin and very slight desquamation were observed. Irritation scores: Erythema: 0.67, Edema: 0.33 After 6 days the effects were reversible. 4 hours exposure time: Direct after patch removal and 30 to 60 min strong subcutaneous bleeding and redbroun discoloration of the skin were observed. The skin was hardened and the animal showed a very strong erythema and edema Necrosis appeared 24 hours p.a. The animal was killed three days p.a..

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
Under conditions tested, the test item is regarded to be corrosive.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Additional information

Skin: There was one report from a study on acute dermal irritation/corrosion [OECD TG 404] in the rabbit (Ciba GmbH Lampertheim, 1992). This study was identified as the key study because it was well conducted and used a current protocol. A 4-hour occlusive exposure to 0.5 g of the unchanged 2,2,6,6 -tetramethylpiperidin-4 -ol, produced moderate to severe skin irritations. The mean score for the 24, 48 and 72 h reading for erythema and edema, respectively was 2.7 and 1.2. In one of three animals the erythema were not reversible within 14 days after patch removal whereas the edema were fully reversible within 10 days.

Conclusion: Since the effects are not reversible 2,2,6,6 -tetramethylpiperidin-4 -ol is corrosive to skin.

Eye: There is no study done to determine eye irritation because 2,2,6,6 -tetramethylpiperidin-4 -ol is corrosive to skin already.

Respiratory irritation: no data available


Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.


As severe irritation effects were observed for skin, 2,2,6,6 -tetramethylpiperidin-4 -ol has to be classified as Category 1C.


 


Respiratory system


Actually, there are no data available for a classification regarding to this endpoint.