Registration Dossier
Registration Dossier
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EC number: 271-487-7 | CAS number: 68564-88-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from July 1989 to October 1989
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- 11-(heptylamino)undecanoic acid
- EC Number:
- 271-487-7
- EC Name:
- 11-(heptylamino)undecanoic acid
- Cas Number:
- 68564-88-5
- Molecular formula:
- C18H37NO2
- IUPAC Name:
- 11-(heptylamino)undecanoic acid
- Test material form:
- solid
- Details on test material:
- CAS N°. 68564-88-5
Test item appearance : white solid
.Batch number : 091137
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Supplier: Charles River
cages: polystyrène ( 560 x 355 x 315 mm).
Temperature of acclimatation: 20 à 26°C
Hygrometry: 33 à 73 % H.R.,
- Diet: approx 150 g per animal et par day (U.A.R. formule 112 - U.A.R., Villemoisson - 91360 Epinay S/Orge - France).
-water : filtered (15 µm), ad libitum (abreuvement automatique). bacteriology check
Animals were acclimatized 7 days before treatment.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0,5 g, per animal
- Duration of treatment / exposure:
- One application, 4hours exposure
- Observation period:
- Readings and observations were done 1, 24, 48 et 72 heures after removing of the semi occlusive paste..
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage: semi occlusive
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation:Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The score for erythema and edema was equal to zero for all animals
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not a skin irritant.
- Executive summary:
The potential irritant and/or corrosive effects of NHAU were evaluated on the skin of New Zealand White rabbits. Each of three rabbits received a 0.5 ml dose of the test article as a single dermal application. The dose was held in contact with the skin under a semiocclusive binder for an exposure period of four heurs. Following the exposure period, the binder was removed. Test sites were subsequently examined and scored for dermal irritation at 1, 24, 48 and 72 hours following patch removal.
Exposure to the test article produced no erythema or edema in any rabbits.Under the condition of the test, the test item, N-heptylamino-11- undécanoïc acid is considered as non-irritant
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