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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
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 Type:
study report
Report date:

Materials and methods

Test guideline
according to 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

Constituent 1
Chemical structure
Reference substance name:
1-Amino-1-cyclopropanecarbonitrile hydrochloride
EC Number:
Cas Number:
Molecular formula:
1-Amino-1-cyclopropanecarbonitrile hydrochloride
Constituent 2
Reference substance name:
1-aminocyclopropane-1-carbonitrile hydrochloride
1-aminocyclopropane-1-carbonitrile hydrochloride

In vivo test system

Test animals

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)

dimethyl sulphoxide
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
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
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
Migrated information
Based on the test protocol and evaluation criteria, the test substance is considered a weak dermal sensitizer.