Cyclohex-1,4-ylenedimethanol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Justification for type of information:

The Human Repeat Insult Patch Test (HRIPT) is a well-accepted sensitization method using human voulenteers as test subjects

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Human Repeat Insult Patch Test

Principles of method if other than guideline:

Human voulenteers have a test article applied to their skin to judge the potential for skin sensitization reactions.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohex-1,4-ylenedimethanol

EC Number:

203-268-9

EC Name:

Cyclohex-1,4-ylenedimethanol

Cas Number:

105-08-8

Molecular formula:

C8H16O2

IUPAC Name:

cyclohexane-1,4-diyldimethanol

Constituent 2

Reference substance name:

[4-(hydroxymethyl)cyclohexyl]methanol

IUPAC Name:

[4-(hydroxymethyl)cyclohexyl]methanol

Constituent 3

Reference substance name:

Cyclohexane-1,4-dimethanol; 1,4-Bis(hydroxymethyl)cyclohexane; CHDM

IUPAC Name:

Cyclohexane-1,4-dimethanol; 1,4-Bis(hydroxymethyl)cyclohexane; CHDM

Details on test material:

-Radioactive test substance as purchased: [Methylol-[14]C] 1, 4-cyclohexanedimethanol
-Source: New England Nuclear, Boston, MA
-Composition as purchased: isomeric mixture of 70% cis- and 30% trans-CHDM
-Specific activity: 7.55 µC/mg
-Purity: >98%

-Radioactive test substance used for dosing: [14]C CHDM isomers were separated by gas chromatography using a thermal conductivity detector and a trapping device; each separated isomer had a purity of >95% when measured by gas chromatography with flame ionization detector. The isomers were combined in a 70% trans-and 30% cis-isomer mixture (to conform with the non-labeled CHDM-R sold by Eastman Organic Chemicals).

-Non-radioactive CHDM used for dosing: mixture of 70% trans- and 30% cis-isomers
-Source: Eastman Organic Chemicals, Rochester, NY

Specific details on test material used for the study:

1,4-Cyclohexanedimethanol CAS Registry No. 105-08-8 Batch# TP07052372

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

Participants: Two hundred eleven (211) subjects completed this study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.

Clinical history:

Inclusion Criteria:
a. Male and female subjects, age 16• and over.
b. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
d. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e. Considered reliable and capable of following directions.

Exclusion Criteria:
a. Ill health.
b. Under a doctor's care or taking medication(s) which could influence the outcome of the study.
c. Females who are pregnant or nursing.
d. A history of adverse reactions to cosmetics or other personal care products.

Route of administration:

dermal

Results and discussion

Results of examinations:

Under the conditions of this study, test material, I, 4-Cyclohexanedimethanol
CAS Registry No. I 05-08-8 Batch# TP07052372, did not indicate a potential for
dermal irritation or allergic contact sensitization.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, test material, I, 4-Cyclohexanedimethanol
CAS Registry No. I 05-08-8 Batch# TP07052372, did not indicate a potential for
dermal irritation or allergic contact sensitization.

Executive summary:

Under the conditions of this study, test material, I, 4-Cyclohexanedimethanol CAS Registry No. I 05-08-8 Batch# TP07052372, did not indicate a potential for dermal irritation or allergic contact sensitization.