Registration Dossier

Administrative data

Endpoint:
immunotoxicity
Remarks:
subacute
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not valid

Data source

Reference
Reference Type:
publication
Title:
Histamine release from mast cells of guinea pig lung
Author:
Eilbeck JT and Smith WG
Year:
1967
Bibliographic source:
J. Pharm. Pharmacol. 19, 374 - 382

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The distribution of mast cells and the effects of antigen on the mast cell population of sensitized guinea pigs have been investigated. The effect of ethanolamine pretreatment on this model was investigated.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): monoethanolamine
- no further data

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Diet: Diet 18 pellets (Oxo Ltd.) ad libitum
- Water: tap water supplemented with 50 mg ascorbic acid (daily) ad libitum

Administration / exposure

Route of administration:
intramuscular
Details on exposure:
Each animal received the equivalent of 200 mg/kg ethanolamine base as hydrichloride each day for three consecutive days by intramuscular injection. the last injection was made 1 hour before death.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
3 days
Frequency of treatment:
daily foe 3 consecutive days
Doses / concentrations
Remarks:
Doses / Concentrations:
200 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
6 animals (sex not given)
Control animals:
no

Results and discussion

Any other information on results incl. tables

Treatment of sensitized animals with ethanolamine did not alter the lung histamine content or the mast cell population. The effect on a subsequent anaphylactic reaction in vitro resulted in reduced histamine and SRS-A release was also reduced. At the same time the shock-induced fall in mast cell count was significantly reduced.

 

The effect of ethanolamine on the histamine content and mast cell count of lungs from groups of six sensitized guinea pigs

Treatment

Total histamine content (µg)

Mean mast cell count

control

82.3 (10.3)

209.5 (38.2)

ethanolamine

88.5 (20.4)

217.5 (39.8)

 Figures in parenthesis are standard deviations

 

The effect of ethanolamine on the release of histamine, the release of SRS-A and the mean mast cell counts of lungs taken from groups of 6 guinea pigs and subjected to anaphylaxis in vitro

Treatment

histamine release (µg)

SRS-A release (units/ml)

Mean mast cell count

control

33.4 (4.7)

24.5 (9.3)

95.5 (17.9)

ethanolamine

21.5* (4.8)

14.8* (4.3)

125.8* (18.6)

Figures in parenthesis are standard deviations

* Difference from control is significant at p = 0.95

srs: slow-reacting substances in anaphylaxis

Applicant's summary and conclusion