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Description of key information

One inhalation, oral and dermal acute toxicity study.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
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
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
No additional details available.
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.
Preliminary study:
No additional information.
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.

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

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 560 mg/kg bw
Quality of whole database:
sufficient

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
Inhalation of saturated vapor by 6 rats for 8 hours.
Inhalation of a cooled mist generated by heating compound to 170°C while air was bubbled through it.
The vapor pressure is 0.3 mm at 20°C and air saturated at this temperature would contain on the order of 400 ppm.
GLP compliance:
no
Remarks:
Conducted before the advent of GLP.
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
No additional details on test aminals and environmental conditions..
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
A group of six albino rats were exposed to of saturated vapor produced at room temperature for 8-hours. Similarly, a group of six albino rats were exposed to a a cooled mist produced by heating the compound to 170°C. while air was bubbled through for 8-hours..
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 8 h
Concentrations:
For the vapor dose, vapor pressure is 0.3 mm. at 20°C. and air saturated at this temperature would contain on the order of 400 ppm.
For the mist dose, cooled mist produced by heating the compound to 170°C. while air was bubbled through.
No. of animals per sex per dose:
6 rats per 8 hour vapor dose and
6 rats per 8 hour mist dose
Control animals:
no
Details on study design:
No additional details on the study design.
Statistics:
No additional details on statistics.
Preliminary study:
No preliminary study data.
Sex:
male
Dose descriptor:
LC0
Effect level:
ca. 400 ppm
Based on:
other: vapor pressure
Exp. duration:
8 h
Mortality:
No deaths after 8 hour exposure.
Clinical signs:
N/A
Body weight:
N/A
Gross pathology:
N/A
Other findings:
N/A

No additional results or table.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Neither air saturated at room temperature nor a mist produced by heating the compound to 170°C, while aerated, killed rates in an 8-hour
exposure. The Vapor hazard is therefore low.
Executive summary:

Neither air staurated at room temperature nor a mist produced by heating the compound to 170oC while aerated, killed rats in an

8-hour exposure. Vapor hazard is therefore low.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
sufficient

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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.
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Single dermal dose
4 or 5/dose level, male albino Rabbits
14-day observation period
Deaths recorded, used to calculate LD50
Procedures detailed in original bound volumes and replicated in publications
GLP compliance:
no
Remarks:
Conducted pior to the advent of GLP.
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Age at study initiation: Not identified.
- Weight at study initiation: See Table 1 Below
Type of coverage:
other: Dermal
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The application of undiluted diisobutyl carbinol to the truck of rabbits under an imprevious sheeting "Vinylite" for 24 hours.
Duration of exposure:
24 Hours
Doses:
2.52, 5.0, 10.0, 20.0 mL/Kg.
No. of animals per sex per dose:
4 animals @ 2.5mL/Kg
5 animals @ all other doses
Control animals:
no
Details on study design:
Single dermal dose
4/low dose levle, 5/all other dose levels, male albino rabbits
24 hour exposure
14-day observation period
Deaths recorded, used to calculate LD50
Procedures detailed in original bound volumes and replicated in publications.
The application of undiluted diisobutyl carbinol to the trunk of rabbits under an imprevious sheeting for 24 hours also produced erratic mortalities
at dosage levels differing by 100?%. Four of 5 rabbits diedat levels of 10 and 20 ml./kg. The R.F. LD50 is 5.66 (2.51 to 12.8) ml./kg. Marked erythema and in
some instances necrosis of the skin were noted. Livers showed varying degrees of congestion and the kidneys were usually pale. There appears to be a wide
variation in individual susceptibility to the action of this compound both by oral dose and skin penetration.
Statistics:
probit method used to calcluate LD50.
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 5.66 mL/kg bw
Based on:
test mat.
95% CL:
ca. 2.51 - ca. 12.8
Mortality:
1/4 @ 2.52 mL/Kg
2/5 @ 5.0 mL/Kg
4/5 @ 10.0 mL/Kg
4/5 @ 20 mL/Kg
Clinical signs:
marked erythema
necrosis
Body weight:
See Talbe 1 for Body Weight changes in 14 days.
Gross pathology:
Liver showed varying degrees of congestion and the kidneys were usually pale.
Other findings:
not applicable

No additional informations or results.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 is 5.66 (2.51 to 12.8) mL./Kg. Marked erythema and in some instances necrosis of the skin were noted. Livers showed varying degrees
of congestion and the kidneys were usually pale. There appears to be a wide variation in individual susceptibility to the action of this compound both by oral dose and skin penetration.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
4 500 mg/kg bw
Quality of whole database:
sufficient

Additional information

Oral:

DIBC has a low order of toxicity when administered by stomach tube to rats. The LD50 is 3.56 g/kg ( 95% Confidence interval 1.43 to 8.86).

Dermal:

Rabbits were exposed dermally to DIBC in a standard acute toxicity study under occlusive conditions. The number of deaths per group were as follows, 1/4 @ 2.52 mL/Kg; 2/5 @ 5.0 mL/Kg; 4/5 @ 10.0 mL/Kg; 4/5 @ 20 mL/Kg. based on this the approximate LD50 is 5.6 ml/kg bw. Based on an approximate density of 0.8 g/ml, this LD50 is approximately 4.5g/kg bw.

Inhalation: Exposure of rats for 8 hours to air saturated with DIBC (approximately 400ppm) produced no mortality. As such the inhalation toxicity of this substance is considered to be low.


Justification for selection of acute toxicity – oral endpoint
reliable study

Justification for selection of acute toxicity – inhalation endpoint
reliable study

Justification for selection of acute toxicity – dermal endpoint
reliable study

Justification for classification or non-classification

The acute oral, dermal and inhalation values demonstrate a low order of toxicity. DIBC therefore does not meet the classification criteria for acute toxicity.