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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-05-04 to 1982-06-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to good clinicl regulations 21CFR parts 50, 56 & proposed ICH guideline
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: Good clinical practices tentative guideline
Deviations:
yes
Remarks:
Clinical histroy and allergic responses of subjects are not given in the report
Principles of method if other than guideline:
According to proposed good clinical guideline. Informed consent were given to subjects.Institional review board reviewed the general protocol for this study.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): OG-Base E 2009.01 (30% C12-C14 dimethylamine oxide)
- Molecular formula (if other than submission substance): na
- Molecular weight (if other than submission substance): 235.7
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: na
- Impurities (identity and concentrations): na
- Composition of test material, percentage of components: see below
- Isomers composition: na
- Purity test date: na
- Lot/batch No.:na
- Expiration date of the lot/batch: July 1982
- Stability under test conditions: na
- Storage condition of test material: Room temperature
- Other:None

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 83
- Sex: Male & female
- Age: Female ( 23 to 65+) and Male (18 & 32)
- Race: na
- Demographic information: Koutsham Lodge Community center,Chelmsford,Essex
- Other: None
Clinical history:
- History of allergy or casuistics for study subject or populations: na
- Symptoms, onset and progress of the disease: na
- Exposure history: na
- Aggravating factors both in home and workplace: na
- Family history: na
- Medical history (for respiratory hypersensitivity): na
- Any other allergic or airway disorders: na
- Smoking history: na
- Other:na
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: na
- Vehicle / solvent: Water
- Concentrations: 0.75 % of test material aqueous solution
- Volume applied: na
- Testing/scoring schedule: 48 hours after each of the 9 induction patches (over 3 weeks) and at 48 and 96 hours after challenge patch application
- Removal of test substance: 24 hour after each each of the 9 induction patch and 24 hour after the challenge patch.
- Other: None


EXAMINATIONS
- Grading/Scoring system: 0=No visible reaction, 1=mild erythematous reaction, 1E= Mild erythematous reaction with papules or edema,2=Moderate erythematous reaction, 2E= Moderate erythematous reaction, 3= Strong erythema, 3E=Strong erythematous reaction with marked oedema, papules and vesicles
- Statistical analysis: na
- Other: None

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: Treatment sites were observed at 48 hours after patching for 3 weeks for the 9 induction exposures. A total of 78 subjects completing the study had mild to moderate erythema of grade 1 & 2.
After 2 weeks of rest, treatment sites were challenged and observed at 48 and 96 hours after patch. A total of 31/78 subjects completing the study had mild erythema of grade 1. No response indicative of skin sensitization was observed.


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/78
- Number of subjects with negative reactions: 78/78
- Number of subjects with equivocal reactions: 0/78
- Number of subjects with irritating reactions: 31/78 exhibited mild skin irritation (grade 1) during challenge.


RESULT OF CASE REPORT: na

OTHER RESULTS: 5 subjects were dropped for reasons unrelated to the test.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
The substance "C10-C16-Alkyl)dimethylamines, N-oxides", test material OG-Base E2009.01 (30% C12-14 Dimethyl amine oxide) did not produce skin sensitization in humans.
Executive summary:

The skin sensitization potential of C12-C14-Alkyl) dimethylamines, N-oxides ( OG-Base E2009.01) was assessed in a human repeat insult patch study. Preliminary irritant study was performed with 0.25% and 0.75% test material aquoues solution and 0.75% concentration was used in main study. A total of 78 subjects were exposed to 9 induction patches containing 0.75% aqueous C12-C14-Alkyl)dimethylamines, N-oxides ( OG-Base E2009.01) under occlusion for a period of 3 weeks. Patches were removed 24 hours after each application and patch sites were graded at 48 hour after patch application prior to the next patch application. After a 2 week rest period, subjects were challenged with 0.75% aqueous C12-C14-Alkyl)dimethylamines, N-oxides ( OG-Base E2009.01) 24 hour patch exposure. Challenge patch sites were graded at 48 and 96 hours after patch application.

83 subjects participated in this study, 78 /83 subjects completed the study. A total of 5 subjects dropped out because of reasons unrelated to the test. 31/78 subjects were observed with mild erythema grade1 during the challenge exposure. No positive responses indicative of delayed contact hypersensitivity was observed. The test material OG-Base E2009.01 (30% C12 -14 Dimethyl amine oxide) did not produce skin sensitization in humans.