Octane-1,2-diol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted in a recognized contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (not conducted in compliance with GLP, limited reporting, only part of the report was available for compilation of the present robust study summary ).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeated insult patch test with 56 volunteers (modified Draize assay) receiving 3 times a week (Monday, Wednesday, Friday) a total of 10 induction applications (48 or 72 h occlusive dressing per application) followed by a 12 day rest period and a 48 h occlusive challenge exposure with the same dose volume as for each induction application. Reactions to the induction exposures were read at patch removal, those to the challenge exposure were read 48 and 96 hours after challenge application start. 4 different formulations were tested simultaneously, two of them containing Octane-1,2-diol.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octane-1,2-diol

EC Number:

214-254-7

EC Name:

Octane-1,2-diol

Cas Number:

1117-86-8

Molecular formula:

C8H18O2

IUPAC Name:

octane-1,2-diol

Method

Ethical approval:

not specified

Subjects:

- Number of subjects: 56 subjects completed the testing
- Sex: 19 males, 37 females
- Age: ≥ 18 years
- Criteria adopted for election of subjects for the present study: See next field "clinical history"

Clinical history:

- Criteria adopted for election of subjects for the present study:
1. Males or females ≥ 18 years old, of any skin type or race.
Degree of skin pigmentation must not significantly interfere with taking the readings of skin reactions.
2. No history of allergy or sensitivity to the types of test material.
3. No requirement for regular medication which would confound study results.
4. No history or evidence of significant active skin pathology which would confound study results.
5. Good general health.
6. Not pregnant or lactating.
7. No history of asthma.

Controls:

No data

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: Human Repeated Insult Patch Test [Modified Draize assay]

ADMINISTRATION
- Type of application: Occlusive to the scapular back
- Description of patch: Finn chamber, 8 mm diameter
- Concentrations: Undiluted test material formulation was administered.
- Volume applied: Ca. 0.025 mL (0.017-0.025 mL) per chamber corresponding to ca. 0.05 mL/cm^2 skin,
for each induction and the challenge applications.
- Scoring schedule/ test material removal: On each occasion* 48 h post patch application start the patches were removed, the skin sites rinsed
with distilled water and responses recorded according to the grading scale listed below.
A further grading was done 96 hours post challenge exposure start

* 10 induction + 1 challenge applications (the latter to a naive skin site), as detailed in the above field "Principles of method if other than guideline"

EXAMINATIONS
- Grading/Scoring system: 0 = No reaction (negative reading)
1 = Erythema throughout the entire patch area
2 = Erythema and edema
3 = Erythema, edema and vesicles
4 = Erythema, edema and bullae
Scoring was performed by experienced personnel of the test facility.
- Other: In addition, other adverse reactions, voluntary subject withdrawals or any tape reactions were recorded.

GENERAL REMARK
4 different formulations were tested simultaneously in the present study, two of them containing Octane-1,2-diol. The present robust study summary is confined to the two tested formulations containing Octane-1,2-diol.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency symptoms observed: 48 h after each of 10 induction application starts and 48 and 96 h after challenge application start.

NO. OF PERSONS WITH/OUT REACTIONS TO "Formulation 1 [4.2% (w/w) octane-1,2-diol]" COMPARED TO STUDY POPULATION
- Number of subjects with positive and/or irritating reactions*: 2/56 (a total of four Grade 1 reactions in two subjects during induction)
- Number of subjects with negative reactions**: 54/56
- Number of subjects with equivocal reactions: 0/56

NO. OF PERSONS WITH/OUT REACTIONS TO "Formulation 2 [5.25% (w/w) octane-1,2-diol]" COMPARED TO STUDY POPULATION
- Number of subjects with positive and/or irritating reactions*: 3/56 (a total of eight Grade 1 reactions in three subjects during induction)
- Number of subjects with negative reactions**: 53/56
- Number of subjects with equivocal reactions: 0/56


* No challenge reactions were observed for any of the tested formulations. Since Grade 1 reactions are minimal irritant responses, the tested formulations were judged neither to be significant irritants nor contact sensitizers.

** to all induction and challenge applications

OTHER RESULTS:
There were no test material related adverse reactions. One subject suffered a transient ischemic attack just prior to the challenge week another one was hospitalized for a kidney infection during challenge week, both of them recovering completely thereafter. These two subjects were not included in the above 56 subjects.

Applicant's summary and conclusion

Conclusions:

Formulations in paraffin containing 4.2% or 5.25% octane-1,2-diol (amongst other ingredients) were tested in a human repeated insult patch test [Modified Draize assay]. Reactions to the challenge application were not evident for any of these formulations. In response to induction applications only Grade 1 reactions were seen in a small number of subjects. Since Grade 1 reactions are minimal irritant responses, the tested formulations were judged neither to be significant irritants nor contact sensitizers.