Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1948-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented and scientifically accpetable. Study conducted before the advent of GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1948
Report Date:
1948

Materials and methods

Principles of method if other than guideline:
Single oral dose
5/dose level, male Wistar
14-day observation period
Deaths recorded, used to calculate LD50
Procedures detailed in original bound volumes and replicated in publications
The R.F. LD50 of diisobutyl carbinol for male albino rats fed a 20%
dispersion in 1.0% "Tergitol" 7 is 3.56 (1.43 to 3.86) gm./kg. The compound
formed an unstable dispersion with "Tergitol" and the broad range for the LD50
may reflect, in part at least, inaccuracies in the individual doses. Death
followed in each instance when prostration or narcosis occurred after dosing. On
the basis of these results, the compound is of the same order of oral toxicity as
undecanol and 2,6-dimethyl heptanol. Ethanol has an LD50 of 13.66gm./kg. and
isopropanol 5.84 gm./kg. by way of comparison.
GLP compliance:
no
Remarks:
Conducted prior to the advent of GLP.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No additional details.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
No additional details available.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 20% dispersion in 1.0% Tergitol in water
Details on oral exposure:
Single oral dose vial stomach tube.
Doses:
1000, 2000, 3980 and 7950 mg/Kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Single oral dose
5/dose level, male Wistar
14-day observation period
Deaths recorded, used to calculate LD50
Procedures detailed in original bound volumes and replicated in publications
The R.F. LD50 of diisobutyl carbinol for male albino rats fed a 20%
dispersion in 1.0% "Tergitol" 7 is 3.56 (1.43 to 3.86) ua./kg. The compound
formed an unstable dispersion with "Tergitol" and the broad range for the LD50
may reflect, in part at least, inaccuracies in the individual doses?. Death
followed in each instance when prostration or narcosia occurred after dosing. On
the basis of these results, the compound is of the same order of oral toxicity as
undecanol and 2,6-dimethyl heptanol.Ethanol has an LD50 of 13.66 gm./Kg and
isopropanol 5.84 gm./kg. by way of comparison.
Statistics:
probit method used to calcluate LD50.

Results and discussion

Preliminary study:
No additional information.
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 560 mg/kg bw
Based on:
test mat.
95% CL:
ca. 1 430 - ca. 8 860
Mortality:
1000 0/5
2000 2/5
3980 3/5
7950 3/5
Clinical signs:
prostration
narcosis
Body weight:
Not available.
Gross pathology:
Not available.
Other findings:
No additional details.

Any other information on results incl. tables

Table 11-129

Disobutyl Carbinol

Single Dose to Male Albino Rats by Mouth

Fed by Stomach Tube as a Dispersion in 1% “Tg” 7, 1ml. – 0.020 gm.

                                     Rat

Number

                         1948

Date

Dosed

                               Grams

Wt.

Weight

Change

in 14

Days

Dosage:

Grams

per

Kilo

                        Dose

in

Grams

Dose in

ml. of

Disper-

sion

                        Days

to

Death

 

 

 

 

 

 

 

 

70259

4-6

90

-

7.95

0.715

3.6

1

70236

108

-

7.95

0.860

4.3

1

70397

106

-

7.95

0.844

4.2

8

70396

90

+ 60

7.95

0.715

3.6

-

70403

106

+ 52

7.95

0.844

4.2

-

 

 

 

 

 

 

 

 

71219

4-13

92

-

3.98

0.366

1.8

1

71223

106

-

3.98

0.422

2.1

4

71231

90

-

3.98

0.358

1.8

3

71229

100

+ 46

3.98

0.398

2.0

-

71230

110

+ 32

3.98

0.438

2.2

-

 

 

 

 

 

 

 

 

72712

5-4

106

-

2.00

0.212

1.1

1

72714

100

-

2.00

0.200

1.0

1

72710

92

+ 18

2.00

0.184

0.92

-

72795

96

+ 50

2.00

0.192

0.96

-

72798

90

+ 40

2.00

0.180

0.90

-

 

 

 

 

 

 

 

 

70408

4-6

106

+ 54

1.00

0.106

0.53

-

70407

90

+ 40

1.00

0.090

0.45

-

70409

98

+ 62

1.00

0.098

0.49

-

70379

94

+ 58

1.00

0.094

0.47

-

70376

100

+ 70

1.00

0.100

0.50

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 is 3.56 (1.43 to 8.86) gm./kg.
Executive summary:

Diisobutyl carbinol is of a low order of toxicity when administered by stomach tube to rats. The LD50 is 3.56 mg/Kg (1.43 to 8.86 gm/Kg).