Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
other: guideline- and GLP-conformant study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
The relative humidity in the animal room was between approximately 36 - 65 % instead of 45 – 65% for several hours. This deviation to the study plan, however, does not affect the validity of the study.
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
The relative humidity in the animal room was between approximately 36 - 65 % instead of 45 – 65% for several hours. This deviation to the study plan, however, does not affect the validity of the study.
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst/The Netherlands
- Age at study initiation: 8-9 weeks (main study), 10-11 weeks (pre-test)
- Weight at study initiation: 18.1-21.4 g
- Housing: group
- Diet: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): approx. 45-65% (except for several hours in which humidity was 36-65%; this deviation does not affect the validity of the study)
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
propylene glycol
Concentration:
0, 5, 10, 25% of test substance
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
For all statistical calculations custom made statistical program ´R` Decision Tree was used. Statistical significance was set at the five per cent level. The Dean-Dixon-Test and the Grubb’s test were used for detection of possible outliers.
Parameter:
SI
Remarks on result:
other: negative control: 1 5% test substance: 1.25 10% test substance: 1.15 25% test substance: 1.36
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: negative control: 1071.5 5% test substance: 1344.5 10% test substance: 1235.5 25% test substance: 1455.1
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The potential of Aluminum, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- to cause skin sensitisation was tested in a Local Lymph Node Assay (LLNA). Therefore, mice were treated with 0, 5, 10, or 25% test substance, and lymphocyte proliferation in the draining lymph nodes after a challenge exposure was used as read-out for sensitisation. The stimulation index determined was between 1.15 and 1.36, and therefore far below the value of 3, above which an EC3 value can be calculated. Therefore, Aluminum, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- was determined to be not sensitising to skin.


Migrated from Short description of key information:
Local lymph node assay(OECD 429, BASF SE, 2015): negative (SI <3)

Justification for selection of skin sensitisation endpoint:
GLP- and Guideline-conformant study with robust study summary

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data do not fulfill the criteria laid out in Regulation (EC) 1272/2008 (CLP). Therefore, non-classification of Aluminium, [(2E)-2 -butenedioato(2 -)-O1]hydroxy- is warranted.