Registration Dossier
Registration Dossier
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EC number: 203-372-4 | CAS number: 106-20-7
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity
- Remarks:
- other: lymphocyte mitogenesis test (in vitro test for immunotoxicity)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Immunotoxicological Evaluation of Environmental Chemicals Utilizing Mouse Lymphocyte Mitogenesis.
- Author:
- Sakazaki, H. et al.
- Year:
- 2 001
- Bibliographic source:
- Journal of Health Science, 47(3) 258-271
Materials and methods
- Principles of method if other than guideline:
- Lymphocytes (isolated from mouse spleen) were stimulated by a polyclonal mitogen specific for either B cells or T cells as an indication of humoral immunity or cell-mediated immunity, respectively, and the effect of the test substance on the lymphocyte proliferation was evaluated.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Kaolin
- Cas Number:
- 1332-58-7
- IUPAC Name:
- Kaolin
- Details on test material:
- - Name of test material (as cited in study report): Bis (2-ethylhexyl) amine
no further data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: C3H/He and BALB/c
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Co. (Sizuoka, Japan)
- Age at study initiation: 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1°C
- Humidity (%): 47 - 67%
Administration / exposure
- Route of administration:
- other: in vitro (after isolation of lymphocytes from mouse spleen)
- Vehicle:
- other: DMSO or distilled water (not specified)
- Details on exposure:
- Vehicle: final concentration of DMSO was 0.3%
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 days (incubation period in the breeder)
- Frequency of treatment:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1 - 200 mmol/L
Basis:
other: on the basis of the solubility to the solvent
- No. of animals per sex per dose:
- not applicable
- Control animals:
- other: yes (control cells)
Results and discussion
Effect levels
- Dose descriptor:
- other: B and T-cell inhibtion
- Effect level:
- 0.1 - 200 other: mmol/L
- Basis for effect level:
- other: No B- and T-cell inhibition was shown within the concentration range tested.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
