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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1960-62
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, study containing basic data which suggests that basic scientific principles have been met. This is sufficient to judge the results reliable as a contribution to the understanding of the toxicity of this substance.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range finding toxicity data: List VI
Author:
Smyth H.F. et al.: Am. Ind. Hyg. Assoc. J. 23, 95, (1962)
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 23, 95
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study pre-dates guidelines. Similar to one day cuff method of Draize (J Pharmac Exp Therap, 82, 377, 1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data.
2-(2-(2-butoxyethoxy)ethoxy)ethanol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5-3.5kg
- Age at study initiation: 3-5 months.
- Other: albino rabbits used.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Fur removed from entire trunk area by clipping
- % coverage:
- Type of wrap if used: impervious plastic film (VINYLITE)

OTHER
- Animals immobilised during 24 hour exposure period.
Duration of exposure:
24 hours
Doses:
2.5, 5.0 and 10ml/kg
No. of animals per sex per dose:
4
Control animals:
other: no but a large number of other substances also tested which acted as reference materials.
Details on study design:
- Duration of observation period following administration: 14 days after wrap removed following 24 hour exposure.
Statistics:
The moving average method was used to calculate the LD50

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 540 mg/kg bw
Based on:
test mat.
95% CL:
> 1 050 - < 11 800
Remarks on result:
other: 1 ml is 1/1000 of a liter, which is a volume. So, if you are trying to convert a liquid it can be achieved with: 1ml = 0.001mg
Mortality:
Three out of four rabbits treated with 10 ml/kg died within 3 days. Two out of four rabbits treated with 5 ml/kg or 2.5 ml/kg, and one treated with 1.25 ml/kg died by day 9.
Body weight:
The surviving animal in the 10ml/kg group lost 110 g of weight over the 14-day recovery period.
Gross pathology:
Findings upon autopsy were cherry red and hemorrhaged lungs, dark livers mottled with prominent acini, and pale and mottled kidneys.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity in rabbits in which only basic details were reported, an LD50 of 3540mg/kg was obtain. Exposure was under occluded conditions. Information available suggests the dose response curve is unusually shallow.
LD50=3540mg/kg bw
Executive summary:

In an acute dermal toxicity in rabbits in which only basic details were reported, an LD50 of 3540mg/kg was obtain. Exposure was under occluded conditions. Information available suggests the dose response curve is unusually shallow.

Synopsis

LD50=3540mg/kg bw