Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 629-718-8 | CAS number: 127946-77-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Skin sensitisation was determined according to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-Amino-1-cyclopropanecarbonitrile hydrochloride
- EC Number:
- 629-718-8
- Cas Number:
- 127946-77-4
- Molecular formula:
- C4H7N2Cl
- IUPAC Name:
- 1-Amino-1-cyclopropanecarbonitrile hydrochloride
- Reference substance name:
- 1-aminocyclopropane-1-carbonitrile hydrochloride
- IUPAC Name:
- 1-aminocyclopropane-1-carbonitrile hydrochloride
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Details on test animals:
- Source: Harlan, Indinapolis.
- Age at study initiation: 8-12 weeks old.
- Weight at study initiation: 17.5 to 22.8 grams.
- Housing: group housing (max 5 per cage).
- Diet: TEK 7012 Rodent diet, ad libitum.
- Water: tap water, ad libitum.
Environmental conditions:
- Temperature: 68°F
- Humidity: 30-70%
- Air changes: 10 to 15 per hr
- Photoperiod 12 hrs light/dark cycle, full spectrum fluorescent lights.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- The test substance was evaluated at 3 different concentrations : 50, 5 and 0.5%.
- No. of animals per dose:
- Five animals per dose group with three concentrations of the test substance.
- Details on study design:
- Detail on study:
Day 1: 25µl of the tested substance or control substance were applied to the dorsum of both ears.
Days 2 & 3: same procedure performed on day 1.
Days 4 & 5: animals were not treated.
Day 6: 5 hours prior to sacrifice, all animals were injected intravenously with 250µl of Phosphate-Buffered Saline containing 20µlCi methyl-3H-thymidine.
The animals were sacrificied by carbon dioxide inhalation and the draining auricular lymph nodes were excised from each animal.
A single suspension of the lymph node cells from each mouse was prepared by gentle mechanical desegregation.
The cell suspension was centrifuged, resuspended in cold 5% TCA, and allowed precipitate at 4°C for 18 hours.
The cells were precipitated and resuspended in cold 5% TCA.
The proliferation response of lymph node cells is expressed as the number of radioactive disintegrations per minute per mouse (DPM/Mouse) and as the Stimulation Index (SI). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The Simulation Index of the positive control animals was 6.95.
The positive control , 25% hexyl cinnamic aldehyde, did induce a Simulation Index greater than 3, thus validating the test system.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Group Test 50% SI: 3.85 Group Test 5% SI: 1.25 Group Test 0.5% SI: 1.35 Negative control SI: NA Positive control SI: 6.95
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Group Test 50% Net DPM Avg.: 277.63 Group Test 5% Net DPM Avg.: 90.42 Group Test 0.5% Net DPM Avg.: 97.71 Negative control Net DPM Avg.: 72.14 Positive control Net DPM Avg.: 501.46
Any other information on results incl. tables
The 5% and 0.5% solutions of the tested substance in DMSO did not induce a Stimulation Index greater than 3 when compared to the vehicle controls. The tested substance did induce a SI greater than 3 when tested at 50%, resulting a SI of 3.85 and a EC3 value of 35.3% (EC3 was calculated by using the concentration and SI values immediately above and below the threshold SI of 3 on the dos response curve).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Based on the test protocol and evaluation criteria, the test substance is considered a weak dermal sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
