Oct-2-ene

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1992-05-11 to 1992-05-13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study is well documented and scientifically acceptable.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Deviations:

no

Principles of method if other than guideline:

Hilltop Research used their study protocol "Evaluation of Primary Irritation Potential in Humans, Single 24-Hour Application" for this study.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-octadecene

IUPAC Name:

1-octadecene

Constituent 2

Reference substance name:

Octadec-1-ene

EC Number:

204-012-9

EC Name:

Octadec-1-ene

Cas Number:

112-88-9

Molecular formula:

C18H36

IUPAC Name:

octadec-1-ene

Details on test material:

- Name of test material (as cited in study report): Neodene 18 (WRC Tox sample 1174)
- Substance type: C18 alpha olefin

Method

Type of population:

general

Subjects:

18 total; 12 females and 6 males

Ethical approval:

confirmed and informed consent free of coercion received

Route of exposure:

dermal

Reason of exposure:

intentional

Details on exposure:

Subjects were administered the test material to both the right and left arms. Application sites were then covered witha semi-occluded patch. Exposure continued for 24 hours, afterwhich the patch was removed. Test sites were scored 30 minutes after patch removal.

Examinations:

Test sites were scored 30 minutes after patch removal. Patch sites were scored according to the scoring scale provided in the study report.

Medical treatment:

No data reported.

Results and discussion

Clinical signs:

Clinical signs were not reported.

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: moderate to strong eythema, oedema and papules were observed in majority of the test subjects when exposed to the 100% dilution of Neodene 18 30 minutes post application. These symptoms of application were also observed at the 24 hour observation.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 17/18 for the 100% dilution.
- Number of subjects with negative reactions: 1/18 for the 100% dilution

RESULT OF CASE REPORT: Strong clinical irrtiation was observed when Neodene 18 was applied at the 100% v/v dilution. Clinical irritation was not observed for the same when applied at the 1%, 10%, and 25% v/v dilution.

Effectivity of medical treatment:

No data reported.

Outcome of incidence:

No data reported.

Any other information on results incl. tables

Table 1. 24-hour Irritation Scores for Neodene^®18
Dose (Neodene 18 % v/v in mineral oil)	Average Irritation Score
100%	4.28 (1.41)
25%	0
10%	0
1%	0
Positive Control – SLS (0.25% v/v)	0.22 (0.73)

N = 18

Values in parenthesis represent standard deviation

Applicant's summary and conclusion

Conclusions:

Diluted solutions of Neodene 18 (1%, 10%, and 25%) produced no evidence of dermal irritation in humans when applied via a semi-occluded patch for 24 hours. Undiluted Neodene 18 produced moderate to severe erythema, edema, and papules under the same test conditions.

Executive summary:

In a dermal irritation study using Neodene 18 diluted (1, 10, and 25% in mineral oil) and undiluted, humans (12 females and 6 males) wereexposed to a single patch application for each test concentration on the upper arm (right and left) for 24 hours. Sodium lauryl sulfate (0.25% in distilled water) served as the positive control. Reactions were scored 30 minutes and 24 hours after patch removal using a numerical and letter grade to indicate severity and type of reaction. The test conditions were appropriate for this study type.

Thirty minutes after patch removal, moderate to strong erythema, edema, and papules were observed on test sites of sixteen subjects exposed to undiluted Neodene 18 with the irritation spreading beyond the test area in six of the subjects. Twenty-four hours after patch removal, seventeen of the test sites exhibited moderate to strong erythema, edema, and papules with the irritation spreading beyond the test sites in nine of the subjects. Diluted solutions of Neodene 18 (1%, 10%, and 25%) produced no evidence of dermal irritation in humans when applied via a semi-occluded patch for 24 hours. Undiluted Neodene 18 produced moderate to severe erythema, edema, and papules under the same test conditions.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study is well documented and scientifically acceptable.