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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
guideline study with acceptable restrictions
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Principles of method if other than guideline:
Measured volumes of undiluted fluid chemicals are placed on the center of the cornea of an ablino rabbit which has just previously been shown to have uninjured eyes, and 24-hours later observe the eye for gross evidence of injury and for corneal necrosis revealed by fluorescein stain. The
volumes used are 0.001, 0.005, 0.02. 0.1 and 0.5 mL.
GLP compliance:
no
Remarks:
Conducted prior to the advent of GLP.
Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
No additional details on animals and environmental conditions.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
An excess of undiluted material.
Duration of treatment / exposure:
24-hour.
Observation period (in vivo):
After 24-hours.
Number of animals or in vitro replicates:
5 eyes.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Remarks:
Only minor damage to the cornea was reported - observed after 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Remarks:
Only minor damage to the cornea was reported - observed after 24 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Remarks on result:
not measured/tested
Remarks:
Only minor damage to the cornea was reported - observed after 24 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
ca. 2
Max. score:
10
Reversibility:
not specified
Remarks on result:
other: Only minor damage to the cornea was reported - observed after 24 hours
Irritant / corrosive response data:
Minor damage to the cornea resulted from the instillation of an excess of undiluted material. This result regulates the compound to Grade 2 in our
10-grade rating series comparable in activity to "Carbitol".

No additional information on results or tables are available.

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Minor damage to the cornea resulted from the instillation of an excess of undiluted material. This result relegates the compound to Grade 2 in our
10-grade rating series comparable in activity to "Carbitol". Carbitol (Diethylene Glycol ethyl ether) is not classified as an eye irritant, therefore DIBC is not considered to be irritating
Executive summary:

Exposure to an excess of undiluted diisobutyl carbinol results in minor damage to the cornea. this result relegates the compound to Grade 2 in our 10 -grade rating series comparable in sensivity to "Carbitol".

Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1948-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
no guideline available
Principles of method if other than guideline:
Apply 0.01mL of undiluted sample to an area of the clipped belly of an albino rabbit and observe the area after 24-hours, recording necrosis, edema,erythema or congestion of capillaries.
GLP compliance:
no
Remarks:
Conducted prior to the advent of GLP.
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No additional data available.
Type of coverage:
open
Preparation of test site:
other: Clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.01mL of undiluted sample.
Duration of treatment / exposure:
Single treatment.
Observation period:
Observed after 24-hours
Number of animals:
5 rabbits
Details on study design:
Apply 0.01mL of undiulted sample to an area of the clipped belly of an albino rabbit and observe the area after 24-hours, recording necrosis, edema,erythema or congestion of capillaries.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
other: assessment was for only 24 hours - no irritation was reported
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
other: assessment was for only 24 hours - no irritation was reported
Remarks:
no indication of irritation
Irritant / corrosive response data:
Diisobutyl carbinol produced minimum detectable capillary injection on 1 of 5 rabbits.
Other effects:
No additional effects noted.

No additional information or table available.

Interpretation of results:
not irritating
Conclusions:
The compound is non irritating to the rabbit skin.
Executive summary:

Apply 0.01mL of undiulted sample to an area of the clipped belly of an albino rabbit and observe the area after 24-hours, recording necrosis, edema, erythema or congestion of capillaries. Diisobutyl carbinol produced minimum detectable capillary injection on 1 of 5 rabbits.

Reason / purpose for cross-reference:
reference to same study
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:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 or test system 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:
other: 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:
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.

Reason / purpose for cross-reference:
reference to other study
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:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 or test system 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:
other: marked erythema necrosis
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:
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.

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

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2,6-dimethylheptan-4-ol and 4,6-dimethylheptan-2-ol
EC Number:
939-420-2
Molecular formula:
C9H20O
IUPAC Name:
Reaction mass of 2,6-dimethylheptan-4-ol and 4,6-dimethylheptan-2-ol
Details on test material:
No additional details.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system 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:
other: prostration narcosis
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:
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).