Registration Dossier
Registration Dossier
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EC number: 236-425-5 | CAS number: 13361-34-7
Skin irritation / corrosion
Administrative data
- 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: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl cyanoacetate
- EC Number:
- 236-425-5
- EC Name:
- 2-ethylhexyl cyanoacetate
- Cas Number:
- 13361-34-7
- Molecular formula:
- C11H19NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyanoacetate
- Reference substance name:
- 2-ethylhexyl-cyanoacetate
- IUPAC Name:
- 2-ethylhexyl-cyanoacetate
- Details on test material:
- - Name of test substance: 2-ethylhexyl-cyanoacetate
- Chemical name: cyanoacetic acid 2-ethylhexyl ester
- Substance number: 96/219
- Batch number: ABL.NR . 13-9844
- CAS number: 13361-34-7
- Degree of purity/content: 98.5 g/100 g (GC)
- Date of manufacturing: 27-DEC-1995
- Physical state/appearance: liquid, yellowish, clear
- Stability under test conditions: The stability of the TS over the study period has been proven by reanalysis.
- Storage conditions: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH (Interfauna, UK)
- Age at study initiation: young adult animals
- Weight at study initiation: 3.19 - 3.98 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet: Kliba Labordiaet 341 (Klingenthalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: approx. 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, upper third of the back or flanks
- Type of wrap if used: The TS has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with Lutrol and Lutrol/Water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to OECD guideline 404 (adopted July 17, 1992) and EEC L 383A, B.4 (December 29, 1992).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The average score (24 to 72 hours) for irritation was calculated to be 0.1 for erythema and 0.0 for edema. The skin findings were reversible in all animals within 48 hours after removal of the patches. Thus the study was terminated after 72 hours.
Any other information on results incl. tables
Irritant/corrosive response data for each individual animal at each time asa well as calculation of the means:
Animal |
Erythema |
Edema |
|
1 hour |
1 |
1 |
0 |
|
2 |
1 |
0 |
|
3 |
1 |
0 |
24 hours |
1 |
1 |
0 |
|
2 |
0 |
0 |
|
3 |
0 |
0 |
48 hours |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
3 |
0 |
0 |
72 hours |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
3 |
0 |
0 |
Mean |
1 |
0.3 |
0.0 |
|
2 |
0.0 |
0.0 |
|
3 |
0.0 |
0.0 |
Total mean |
|
0.1 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen and considering the described findings the TS does not give indication of an irritant property to the skin.
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