Registration Dossier

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

Constituent 1
Chemical structure
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:
- 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 and 2000 µl/kg: strong staggering, apathy, latero-abdominal position, intermittently respiration, anancasm to chew, lacrimation, salivation, spasms; 7 days after application animals were without any abnormal findings
- 1600 and 200 µl/kg: above symptoms appeared in a weakened manner
After an observation period of 7 days, survivours were sacrificed and necropsied
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