2,4,7,9-tetramethyldec-5-yne-4,7-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Five groups of five male albino rats of the Sherman-Wistar
Strain weighing between 200 and 300 gm were employed in
this study. The rats were deprived of food but not water
for 24 hours prior to dosing. Each animal was weighed and
dosed by direct administration of the experimental material
into the stomach by means of a syringe and dosing needle.

GLP compliance:

not specified

Remarks:

test done before GLP was established

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,5,8,11-tetramethyldodec-6-yne-5,8-diol

EC Number:

269-348-0

EC Name:

2,5,8,11-tetramethyldodec-6-yne-5,8-diol

Cas Number:

68227-33-8

Molecular formula:

C16H30O2

IUPAC Name:

2,5,8,11-tetramethyldodec-6-yne-5,8-diol

Constituent 2

Reference substance name:

2,5,8,11-tetramethyl-5,8-dodecanediol

IUPAC Name:

2,5,8,11-tetramethyl-5,8-dodecanediol

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Each animal was dosed by direct administration of the experimental material
into the stomach by means of a syringe and dosing needle.

Doses:

1 g/kg
2 g/kg
4 g/kg
8 g/kg
16 g/kg

No. of animals per sex per dose:

five animals (males) per dose

Control animals:

no

Details on study design:

Five groups of five male albino rats of the Sherman-Wistar
Strain weighing between 200 and 300 gm were employed in
this study. The rats were deprived of food but not water
for 24 hours prior to dosing. Each animal was weighed and
dosed by direct administration of the experimental material
into the stomach by means of a syringe and dosing needle.

Statistics:

The subject material when studied in male albino rats has
an acute oral LD of 12.9 gm/kg. with 19/20 Confidence
limits of from 8?8 to 20.1 gm/kg

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

12 900 mg/kg bw

Based on:

test mat.

95% CL:

> 8 400 - < 20 100

Mortality:

one animal within 24 hours in the 8 g group
one animal within 24 hours and two within 48 hours in the 16 g group

Clinical signs:

other: At the dosage levels of 1.0 and 2.0 gm/kg. the animals were ruffled, dirty and slightly depressed after 24 hours. They appeared recovered and normal after 48 hours. At the dosage level of 4.0 gm/kg. the animals were depressed after 4-6 hours. Within 24 ho

Gross pathology:

In the gross pathologic examination, slight hemorrrhaging of the GI tract was evident in those animals dying during
the course of the study. Gross pathologic examination of the animals sacrificed a t the conclusion of the observation
period revealed nothing remarkable.

Any other information on results incl. tables

Dosage Level g/kg	Number of Animals Dosed	1	2	3	4	5	6	7	8	9	10	11	12	13	14	Total Dead 14 Days	Total Survived 14 Days	Average Initial Weight [g]	Average Final Weight [g]
1.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	235	280
2.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	220	250
4.0	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	240	275
8.0	5	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4	210	235
16.0	5	1	2	0	0	0	0	0	0	0	0	0	0	0	0	3	2	220	245

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The subject material when studied in male albino rats has
an acute oral LD50 of 12.9 gm/kg. with 19/20 Confidence
limits of from 8.4 to 20.1 gm/kg.

Executive summary:

The subject material when studied in male albino rats has an acute oral LD50 of 12.9 gm/kg. with 19/20 Confidence limits of from 8.4 to 20.1 gm/kg.