Registration Dossier
Registration Dossier
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EC number: 279-242-6 | CAS number: 79720-19-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione
- EC Number:
- 279-242-6
- EC Name:
- 3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione
- Cas Number:
- 79720-19-7
- Molecular formula:
- C25H46N2O2
- IUPAC Name:
- 3-dodecyl-1-(2,2,6,6-tetramethylpiperidin-4-yl)pyrrolidine-2,5-dione
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.4 kg
- Housing:individually in stainless stell cages
- Diet (e.g. ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, Soest, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1 °C
- Humidity (%): 60+/-5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 31.07. To: 06.08.1984
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml of the test product to approx. 6 cm² skin area.
- Duration of treatment / exposure:
- Skin reaction was assessed and recorded at 1 and 24 h after removal of the dressing and after 48 h and 72 h and after 6 days.
- Observation period:
- 6 days
- Number of animals:
- 3 males, 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with yellow-brown spots (2 animals); area of application with red-brown spots (1 animal)
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with red-brown spots; induration of the area of application
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: induration of the area of application; severe necrosis with vesiculation over the entire area of application; edges of the area of application dark red (1 animal)
- Irritation parameter:
- erythema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: severe necrosis with vesiculation over the entire area of application
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with yellow-brown spots (2 animals); area of application with red-brown spots (1 animal)
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: area of application grey-white, edges of the area of application dark red; area of application with red-brown spots; induration of the area of application
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: edges of the area of application dark red (2 animals); induration of the area of application; severe necrosis with vesiculation over the entire area of application
- Irritation parameter:
- erythema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: severe necrosis with vesiculation over the entire area of application
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- males
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: open weeping wounds, bleeding cracks
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- females
- Basis:
- mean
- Time point:
- other: 6 days
- Reversibility:
- not specified
- Remarks on result:
- other: open weeping wounds, bleeding cracks
Any other information on results incl. tables
After 6 days, the experiment was terminated due to severe effects.
The irritation index was 6.13/8 and hence a single dermal application of 0.5 ml of the product is very irritant for male and female rabbits.
Evaluation in accordance with Appendix VI of the Sixth Amendment (79/831/EEC):
Erythema: x = 4.0
Oedema: x = 2.78
There was necrosis formation after an exposure time of only 3 minutes.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The substance is skin corrosive.
- Executive summary:
The substance is skin corrosive.
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