Registration Dossier

Administrative data

Description of key information

Reliability 2 studies for skin and eye irritation

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
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:
other: Study conducted prior to the advent of GLP.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other 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 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.
Irritant / corrosive response data:
Diisobutyl carbinol produced niminum 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
Remarks:
Migrated information Criteria used for interpretation of results: not specified
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
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:
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:
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:
cornea opacity score
Basis:
animal:
Time point:
other: 24-hour
Score:
ca. 2
Max. score:
10
Reversibility:
not specified
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:
Migrated information 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".

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a reliability 2 study, DIBC was not considered to be irritating to the skin.

Eye irritation

In a reliability 2 study rabbit eyes were exposed to an excess of DIBC. This resulted in minor damage to the cornea placing it into category 2 out of 10, considered to be mildly irritating.

Justification for classification or non-classification

DIBC is not considered to be irriating to the skin.

The data available on eye irritation are insufficient on their own to assign a classification according to CLP (and GHS). However, this substance was considered to be a grade 2 eye irritant (on a scale of 1 -10). This grade of 2 for irritation is also assigned to other materials such as Diethylene Glycol ethyl ether. This substance is not classified as irritating to the eyes, therefore by analogy, DIBC is not considered to be an eye irritant according to CLP (and GHS).