Registration Dossier
Registration Dossier
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EC number: 258-207-9 | CAS number: 52829-07-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.07.82 - 19.07.82
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The animals were exposed under occlusion for 24 hours (instead of 4 hours under semi-occlusion: OECD404). This represents a worst case situation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate
- EC Number:
- 258-207-9
- EC Name:
- Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate
- Cas Number:
- 52829-07-9
- Molecular formula:
- C28H52N2O4
- IUPAC Name:
- bis(2,2,6,6-tetramethylpiperidin-4-yl) sebacate
- Details on test material:
- - Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male/female
- Source: Kleintierfarm Madoerin AG, CH4414, Fuellinsdorf
- Age: not indicated
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 3/sex
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the back
The shaven skin on one side was slightly scarified with the help of a "Schroepfschnaepper", Aesculap, Switzerland.
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated
SCORING SYSTEM: similar to OECD404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- Minimal erythema formation were observed (maximum score of 1) in 4/6 animals, reversible within 72 hours the latest. Minimal edema formation were observed (maximum score of 1) in 2/6 animals, reversible within 48 hours the latest. Exposure of the abraded skin gave similar results.
- Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating
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