Registration Dossier
Registration Dossier
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EC number: 810-213-8 | CAS number: 1370461-06-5
Skin sensitisation
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:
- other: guideline- and GLP-conformant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
- EC Number:
- 810-213-8
- Cas Number:
- 1370461-06-5
- Molecular formula:
- C4 H3 Al O5
- IUPAC Name:
- sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
- Details on test material:
- - Name of test material (as cited in study report): Aluminum, [(2E)-2-butenedioato(2-)- O1]hydroxy-
- Physical state: white solid
- Analytical purity: Al-fumarate-OH: 85.8 g/100 g (Determined by 1H-NMR-spectroscopy)
- Batch No.: 13-0001-2
- Expiry date: 30 September 2016
- Storage condition of test material: at room temperature
- Other: The test item appeared to be homogeneous
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (LLNA)
- 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.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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