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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

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

Constituent 1
Chemical structure
Reference substance name:
2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate
Cas Number:
5486-79-3
Molecular formula:
C12H20ClNO5
IUPAC Name:
2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TOXI-COOP ZRT, H-1103, Budapest, Cserkesz u. 90
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified] yes
- Age at study initiation: 11-12 weeks old
- Weight at study initiation: 18.9-21.7 g
- Housing: Grouped caging (4 animals/cage)
- Diet (e.g. ad libitum): ssniff Rat/Souris-Elevage E complete diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12-12

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
25, 10, 5, 2.5% (w/v)
No. of animals per dose:
Dose Range Finding
6 animals (2 animals/groups)

Main Test
28 animals (4 animals/treatment group)

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
No mortality, cutaneous reactions or signs of toxicity were obserev in the positive control group.

In vivo (LLNA)

Results
Parameter:
SI
Value:
>= 1.3 - <= 2.8
Test group / Remarks:
25%, 10%, 5%, 2.5%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present assay, 3,4-O-dimethyl methyldopa monohydrochloride monohydrate (DMAKS) tested at the maximum attainable concentrations of 25% (w/v, based on solubility) and at concentrations of 10 %, 5 % and 2.5 % (w/v) as formulations (apparently solutions) in a suitable vehicle (DMF) was shown to have no skin sensitization potential in the Local Lymph Node Assay.
According to the effective regulations [5, 6] concerning to the classification, labelling and packaging of substances and mixtures no specific label elements regarding to skin sensitization potential of the test item should be used for 3,4-O-dimethyl methyldopa monohydrochloride monohydrate (DMAKS).