Registration Dossier

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:
2001
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Bis (2-ethylhexyl) amine
no further data

Test animals

Species:
mouse
Strain:
other: C3H/He and BALB/c
Sex:
male
Details on test animals 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