Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1960-62
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
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. Rationale for using a read across substance is included in summary record for this end point.

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1960
Report date:
1960
Reference Type:
publication
Title:
Range finding toxicity data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel BS
Year:
1962
Bibliographic source:
Am Ind Hyg Ass J, 23, 95

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

Constituent 1
Reference substance name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
EC Number:
205-592-6
EC Name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
Cas Number:
143-22-6
IUPAC Name:
2-[2-(2-butoxyethoxy)ethoxy]ethanol
Details on test material:
no data.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system 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
95% CL:
> 1 050 - < 11 800
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.
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
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