Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1945
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study containing sufficient details to regard it as reliable for use in hazard assessment.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1945
Report Date:
1945
Reference Type:
publication
Title:
Further experience with the range finding test in the industrial toxicology laboratory
Author:
Smyth HF, Carpenter CP
Year:
1948
Bibliographic source:
Ind Hyg Toxicol 40, 63

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Carbitol, ethoxy triglycol, ethoxytriethylene glycol

Test animals

Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
Weight: 87-124g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% 'Tergitol' 7; 1ml=0.5g
Details on oral exposure:
no data
Doses:
7.95, 8.9, 10.0, 12.6g/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
14 days observation.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
10 610 mg/kg bw
95% CL:
> 9 980 - < 11 280
Mortality:
In large doses death resulted in 1-2 days. A dose close to the LD50 caused death in 2-4 days.
Clinical signs:
Narcosis from large doses was marked.
Body weight:
Survivors gained weight well.
Gross pathology:
In animals that died in 2-4 days, pale kidneys and orange bile was observed. In rats which died after two days congestion and cloudy swelling of kidney and liver were found, more severe in the former. There was congestion in one spleen. Survivors of such a dose 14 days later had liver and kidney seen to be normal microscopically.
Other findings:
no data

Any other information on results incl. tables

Table 1. Single doses to rats by gavage

Dose (g/kg)

Number of animals dosed

Number of animals dead

12.6

10

9

10.0

10

6

8.9

10

1

7.95

10

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on results of this study the substance is not classified
Executive summary:

In an old but reliable acute oral toxicity study, male albino rats were administered single doses of 2-(2-(2-ethoxyethoxy)ethoxy)ethanol by gavage. The LD50 was calculated at 10.61g/kg.