3,6,9,12-tetraoxahexadecan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Principles of method if other than guideline:

Method: BASF-Test.
In principle, the methods described in OECD Guideline 401 were used.
5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in water. Group-wise documentation of clinical signs was performed over the 7day study period. The clinical signs and findings were reported in summary form. On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,6,9,12-tetraoxahexadecan-1-ol

EC Number:

216-322-1

EC Name:

3,6,9,12-tetraoxahexadecan-1-ol

Cas Number:

1559-34-8

Molecular formula:

C12H26O5

IUPAC Name:

3,6,9,12-tetraoxahexadecan-1-ol

Details on test material:

- Name of test material (as cited in study report): Butyltetraglykol, Tetraäthoxybutanol
- Molecular formula (if other than submission substance): C4H9(OC2H4)4-OH
- Physical state: liquid
- Analytical purity: 90%

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

6400, 3200, 2500, 2000, 1600, 200 ul/kg

No. of animals per sex per dose:

5 male and 5 female rats per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Statistics:

Probit fit

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 630 mg/kg bw

95% CL:

2 360 - 2 900

Remarks on result:

other: based on conversion of volume dose to weight

Mortality:

see table below

Clinical signs:

other: - after application calm behaviour, one hour later abdominal position, narcosis-like condition, dyspnea, exophthalmos, lacrimation, salivation, apathy - 6400 µl/kg: all animals perished - 3200 µl/kg: survivors were calm for 1 week and recovered - 2500 an

Gross pathology:

no abnormalties detected

Other findings:

- 3 x chron. bronchitis and brochiectasis

Any other information on results incl. tables

Mortalities:

Dose in µl	Concentration in %	No. of animals	Perished within
			1 h	24 h	48 h	7 d	14 d
6400 3200 2500 2000 1600 200	30 30 20 20 8 2	10 10 10 10 10 10	9/10 4/10 0/10 0/10 0/10 0/10	10/10 6/10 4/10 4/10 0/10 0/10	10/10 7/10 4/10 4/10 0/10 0/10	10/10 7/10 4/10 4/10 0/10 0/10	- - - - - -

LD50 ca.: 2650 µl/kg after 7 days

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In an old but well reported acute oral toxicity study than followed the key principles of a guideline study, the substance 3,6,9,12-tetraoxahexadecan-1-ol was given to rats in single oral doses up to 6400ul/kg and the rats observed for 7 days. Based on the level of mortality seen, an LD50 of around 2600mg/kg was determined.

Synopsis

LD50(oral)=2630mg/kg