Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: performed in accordance with OECD and GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
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

Constituent 1
Chemical structure
Reference substance name:
N-(4-acetylaminophenyl)-3-hydroxynaphthalene-2-carboxamide
EC Number:
255-419-3
EC Name:
N-(4-acetylaminophenyl)-3-hydroxynaphthalene-2-carboxamide
Cas Number:
41506-62-1
Molecular formula:
C19H16N2O3
IUPAC Name:
N-(4-acetamidophenyl)-3-hydroxy-2-naphthamide

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
-strain: CBA/CaOlaHsd
- Source: Harlan Netherlands
- Age at study initiation: 6-7 weeks (beginning of acclimatization)
- Weight at study initiation: 17.0 g to 21.4 g
- Housing: single caging, Makrolon Type I, with wire mesh top, granulated soft wood bedding
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 84 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
1. experiment: 0.1, 0.2, 0.4, 1.0, 5.0% (w/v)
2. experiment: 5.0, 10.0, 20.0% (w/v)
No. of animals per dose:
4 animals per treatment group, 4 animals in the control group
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
EC3: 18.2% (w/v)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The S.I. were: 1. experiment: 1.13, 1.27, 1.27, 1.37 and 1.62 for concentrations of 0.1, 0.2, 0.4, 1.0 and 5.0% in DMSO (w/v) respectively. 2. experiment: 2.04, 2.00 and 1.78 for concentrations of 5, 10 and 20% in DMSO (w/v) respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Results expressed as mean per group 1. experiment: Group -- DPM per lymph node -- SI Vehicle -- 550.0 0.1% -- 622.7 -- 1.13 0.2% -- 695.9 -- 1.27 0.4% -- 696.9 -- 1.27 1.0% -- 752.3 -- 1.37 5.0% -- 992.0 -- 1.62 1. experiment: Group -- DPM per lymph node -- SI Vehicle -- 483.0 5.0% -- 984.7 -- 2.04 10.0% -- 967.5 -- 2.00 20.0% -- 859.2 -- 1.78

Any other information on results incl. tables

No deaths, clinical signs or abnormal body weight development were observed during the study period.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was found not to be a skin sensitiser in the LLNA when tested at 0.1, 0.2, 0.4, 1, 5, 10 and 20% in DMSO (w/v).
An EC3 value could not be calculated, since all S.I.´s are below 3.