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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.
according to guideline
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
Type of study:
mouse local lymph node assay (LLNA)
Details on test animals and environmental conditions:
Strain: Mice, CBA/CaOlaHsd. Supplier: Harlan Winkelman GmbH, D-33176 Borchen.Sex, specification: Females, healthy young adult nulliparous animals.Age of the animals: About 8 weeks at the first administration.Weight range of the animals at the first application: 16.9 - 22.3 g.Hygiene: Optimal hygienic conditions.Room temperature: Average of 22.0 °C (continuous monitoring and recording).Relative humidity: Average of 46.1 % (continuous monitoring and recording).Light: Only artificial light from 6.00 a.m. to 6.00 p.m.Cages: Single caging. Makrolon cages type II, (22 cm x 16,5 cm ground area, 15 cm high).Feed: Altromin maintenance diet for rats and mice, item No. 1324forte, ad libitum.Random samples of the feed are analysed for contaminants.Water: Tap water offered in Makrolon-bottles with stainless steel canules, ad libitum.Bedding material: Wood chips (aspen) Fa. ABEDD Dominik Mayr KEG, A 8580 Köflach. Reduction of microorganisms by autoclaving.Acclimatisation: 6 days.Identification of the animals: By shearing a defined fur region on the back of the animal.
Group Substances concentrationstotal amount of substance applied/animal A (low dose)25 % test substance37.5 mgB (mid dose)50 % test substance75 mgC (high dose)62.1 % test substance93.2 mgK (negative control) DMF 150 mgP (positive control) 25 % HCA in AOO (v/v)37.5 mgHCA: Hexyl cinnamic aldehyde.AOO: Acetone:olive oil (4:1, v/v).
No. of animals per dose:
Number of animals: 5 animals/group:3 test substance groups,negative control group, positive control group.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Results are presented as test/control ratio (Stimulation index, SI), calculated as dpm test group/dpm negative control group.(dpm = disintegrations per minute, corrected by the subtraction of the background)A substance is regarded as a sensitizer in the LLNA if the test substance induces a 3-fold or greater increase in 3HTdR incorporation into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes, as indicated by the SI, together with the consideration of dose response.
Positive control results:
Application of 25 % HCA in AOO resulted in an Stimulation Index (SI) of 5. This result proves the sensitivity of the strain of animals used and the reliability of the experimental technique.HCA: Hexyl cinnamic aldehyde.AOO: Acetone:olive oil (4:1, v/v).
Remarks on result:
other: The SIs of the test substance groups were between 0.8 and 1.7.
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Group dpm SInegative control 1964 1low dose 2602 1.3mid dose 1556 0.8high dose 3387 1.7positive control 49834 25.4

No abnormal behaviour or clinical signs were detected during the experiment in the animals.

No local irritations were observed at the application sites of all animals of all test substance groups and the negative control group throughout the whole study.

On Days 3-5 all animals of the positive control group had slight erythema at the application sites indicating slight irritative skin reactions.

Interpretation of results:
not sensitising
Migrated informationCriteria used for interpretation of results: EU
Diacetone acrylamide is regarded as a non sensitizer in the LLNA according to the OECD-Guideline 429, "Skin Sensitisation: Local Lymph Node Assay", since the SIs of all examined test substance concentrations were clearly below 3.
Executive summary:

The Local Lymph Node Assay was performed to evaluate a possible skin sensitising potential of diacetone acrylamide according to the OECD-Guideline 429.

The stimulation indexes SIs of the tested test substance concentrations were 1.3 (low dose), 0.8 (mid dose) and 1.7 (high dose). The positive control substance led to a stimulation index of 25.4, thus demonstrating the validity of the experiment.

According to the OECD-Guideline 429, "Skin Sensitisation": Local Lymph Node Assay", diacetone acrylamide is not regarded as a skin sensitier in the LLNA.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Diacetone acrylamide is not regarded as a sensitizer in the LLNA.

Justification for selection of skin sensitisation endpoint:
Guideline study with GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No indications were obtained to justify a classification.