Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not reported.
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study which does not give sufficient experimental details and is only listed in short abstracts and is therefore not assignable for reliability.

Data source

Reference
Reference Type:
publication
Title:
Toxicity of Ethylene Dibromide Determined on Experimental Animals.
Author:
Rowe, V.K., Spencer, H.C., McCollister, D.D., Hollingsworth, R.L. & Adams, E.M.
Year:
1952
Bibliographic source:
Arch. Ind. Hyg. Occup. Med., Vol. 6, p.158-173.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The method used was that of Draize et al, 1944. except that the empervious sleeves were covered by heavy cloth bandages and animals weere allowed the freedom of their cages.

Draize, J.H.; Woodard, G. & Calvery, H.O. (1944) Methods for the study of irritation and Toxicity of substance applied topically to the skin and mucous membranes, J. Pharmacol. & Exper. Therap. Vol. 82, pp. 377-390.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The material used in the caute oral-dose, eye-contact and skin-contact studies was of regular commercial quality having a purity of approximately 99%. Specification for such a product include the following: the specific gravity at 25/25ºC must be between 2.165 and 2.185; 5 to 95% by volume must boil within 2ºC and include the temperature 131.5ºC; the melting point minimum is 8.8ºC.
Radiolabelling:
no

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
Rabbits, not otherwise specified.

ENVIRONMENTAL CONDITIONS
not reported.

IN-LIFE DATES:
not reported.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
0.21, 0.3, 0.65 & 1.1 gm/kg.
No. of animals per group:
0.21 gm/kg group: 15 animals
0.3, 0.65 & 1.1 gm/kg groups: 5 animals each dose.
Control animals:
no
Details on study design:
The method used was essentially that of Draize et al, 1944, except that the impervious sleeves were covered by heavy cloth bandages and the animals were allowed the freedom of their cages. In all cases the exposures lasted for 24 hours, after which the sleeves were removed and the exposed areas cleansed with soap and water. The animals were observed for two weeks after the test, or until it was certain that they had recovered from the effects of the exposure.
Details on in vitro test system (if applicable):
not applciable.

Results and discussion

Signs and symptoms of toxicity:
yes
Remarks:
At all dosage levels the animals exhibited a marked depression of the central nervous system. With the higher dosage levels there was a sufficient drop in body temperature to cause the animals to feel cold to the touch. Deaths occured within four days or
Dermal irritation:
yes
Remarks:
In all cases the material produced a moderate to severe effect upion the skin Erythema, edema and necrosis were always present. Healing with scar formation was the rule.
Absorption in different matrices:
not reported.
Total recovery:
not reported.
Conversion factor human vs. animal skin:
not reported.

Any other information on results incl. tables

Table 2. Mortality of Rabbits Caused by Ethylene Dibromide Adsorbed Through the Intact Skin.

Amount of CH2Br-CH2Br Applied (Gm/Kg) Period of Contact (Hr.) Total Number of Rabbits Number that Died
0.21 24 15 1
0.3 24 5 2
0.65 24 5 4
1.1 24 5 5

Applicant's summary and conclusion

Conclusions:
The substance permeated the skin and caused toxic effects in all test groups tested.