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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 05, 2016 - feb 02, 2017
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (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:
4-dimethylaminobenzaldehyde
EC Number:
202-819-0
EC Name:
4-dimethylaminobenzaldehyde
Cas Number:
100-10-7
Molecular formula:
C9H11NO
IUPAC Name:
4-(dimethylamino)benzaldehyde
Test material form:
solid
Specific details on test material used for the study:
Identification:
Art. 803057 (4-(Dimethylamino)benzaldehyde)
Batch:
S6886257
Purity:
Assay (HClO4): 99.4% Assay (GC, area%): 99.6% (a/a)
Appearance:
Grey-blue, crystalline powder
Expiry Date:
31 May 2019
Storage Conditions:
(provided by the Sponsor)
At room temperature, protected from light, tightly closed and dry.*
Stability in Solvent:
Not indicated by the Sponsor

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 10-12 weeks; Main test: 10 - 12 weeks
- Weight at study initiation: Pre-test: 19.4 and 20.6 g; Main test: 17.9 - 24.4 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24.3°C
- Humidity (%): 45 – 65 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
5, 10, and 25%. (w/w)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 50 % in DMF
- Irritation: slight erythema score 1
- Lymph node proliferation response: -

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3

TREATMENT PREPARATION AND ADMINISTRATION:
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Positive control results:
Conc. SI
0%: 1.00
5% 1.50
10% 3.84
25% 11.76

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.9
Test group / Remarks:
Test Group: 10 %
Parameter:
SI
Value:
3.1
Test group / Remarks:
Test Group: 25 %
Parameter:
SI
Value:
1.9
Test group / Remarks:
Test Group: 50 %

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The test item Art. 803057 (4-(Dimethylamino) benzaldehyde) was a skin sensitiser under the test conditions showing a low to moderate potency. Based on these data, a classification for skin sensitisation of 1B is justified.