Registration Dossier
Registration Dossier
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EC number: 848-720-1 | CAS number: 1616494-50-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 January 2019 - 29 Janauary 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- The relative humidity in the animal room was between approximately 12.7-45% instead of 45–65% for few hours (defective air humidifier) The purity of acetone was updated. These deviations to the study plan, however, do not affect the validity of the study.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N-Di-(2-Ethylhexyl)-amino Isostearamide
- EC Number:
- 848-720-1
- Cas Number:
- 1616494-50-8
- Molecular formula:
- C34H69NO
- IUPAC Name:
- N,N-Di-(2-Ethylhexyl)-amino Isostearamide
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Netherlands
- Age at study initiation: 9-10 weeks
- Housing: 5 per cage in Makrolon Type II (pre-test) / III (main study), with wire mesh top
- Diet: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Photoperiod (hrs dark / hrs light): 12/ 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, and 25%
- No. of animals per dose:
- 5
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 1
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- ca. 1.6
- Test group / Remarks:
- 1.2
- Parameter:
- SI
- Value:
- ca. 1.2
- Test group / Remarks:
- 25%
Any other information on results incl. tables
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. From day 1 to 6, the animals showed a very slight erythema of the ear skin (Score 1).
In this study Stimulation Indices (S.I.) of 1.0, 1.6, and 1.2 were determined with the test item at concentrations of 5, 10, and 25% in acetone/olive oil (4+1, v/v), respectively.
The test item was not a skin sensitiser under the test conditions of this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not a skin sensitiser under the test conditions of this study.
- Executive summary:
The test item was not a skin sensitiser under the test conditions of this study.
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