Registration Dossier
Registration Dossier
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EC number: 203-427-2 | CAS number: 106-72-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- July 1981
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: KLIGMAN, A. (1966) The Identification of Contact Allergens by Human Assay, III. The Maximisation Test: A Procedure for Screening and Rating Contact Sensitizers. THE JOURNAL OF INVESTIGATIVE DERMATOLOGY. 47 (5). p393-409.
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP introduction
Test material
- Reference substance name:
- 2,6-dimethylhept-5-enal
- EC Number:
- 203-427-2
- EC Name:
- 2,6-dimethylhept-5-enal
- Cas Number:
- 106-72-9
- Molecular formula:
- C9H16O
- IUPAC Name:
- 2,6-dimethylhept-5-enal
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 2,6-DIMETHYL 2-HEPTENAL (81-5-11)
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: Homo sapiens
- Details on test animals or test system and environmental conditions:
- Twenty-nine healthy adult male and female volunteers were screened and twenty-two completed the study.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- yes
- Duration of treatment / exposure:
- 72 hours
- Observation period:
- 72 hours
- Number of animals:
- 22
- Details on study design:
- see below
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- Data sheets with final tabulations are shown below. 5% SLS produced very little irritation in this group.
Any other information on results incl. tables
2,6-DIMETHYL 2-HEPTENAL 7
| Subject No. | Challenge | |||
| SLS | NO SLS | |||
| 48-hrs | 72-hrs | 48-hrs | 72-hrs | |
| 1 | N | N | N | N |
| 2 | N | N | N | N |
| 3 | N | N | N | N |
| 4 | Disqualified | |||
| 5 | N | N | N | N |
| 6 | Cancel | |||
| 7 | Cancel | |||
| 8 | N | N | N | N |
| 9 | N | N | N | N |
| 10 | N | N | N | N |
| 11 | N | N | N | N |
| 12 | N | N | N | N |
| 13 | N | N | N | N |
| 14 | N | N | N | N |
| 15 | Cancel | |||
| 16 | N | N | N | N |
| 17 | Cancel | |||
| 18 | N | N | N | N |
| 19 | N | N | N | N |
| 20 | N | N | N | N |
| 21 | N | N | N | N |
| 22 | N | N | N | N |
| 23 | N | N | N | N |
| 24 | N | N | N | N |
| 25 | N | N | N | N |
| 26 | N | N | N | N |
| 27 | Cancel | |||
| 28 | N | N | N | N |
| 29 | Cancel | |||
Petrolatum Control
| Subject No. | Challenge | |||
| SLS | NO SLS | |||
| 48-hrs | 72-hrs | 48-hrs | 72-hrs | |
| 1 | N | N | N | N |
| 2 | N | N | N | N |
| 3 | N | N | N | N |
| 4 | Disqualified | |||
| 5 | N | N | N | N |
| 6 | Cancel | |||
| 7 | Cancel | |||
| 8 | N | N | N | N |
| 9 | N | N | N | N |
| 10 | N | N | N | N |
| 11 | N | N | N | N |
| 12 | N | N | N | N |
| 13 | N | N | N | N |
| 14 | N | N | N | N |
| 15 | Cancel | |||
| 16 | N | N | N | N |
| 17 | Cancel | |||
| 18 | N | N | N | N |
| 19 | N | N | N | N |
| 20 | N | N | N | N |
| 21 | N | N | N | N |
| 22 | N | N | N | N |
| 23 | N | N | N | N |
| 24 | N | N | N | N |
| 25 | N | N | N | N |
| 26 | N | N | N | N |
| 27 | Cancel | |||
| 28 | N | N | N | N |
| 29 | Cancel | |||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2,6-DIMETHYL 2-HEPTENAL produced no reactions and were not considered significantly irritant or allergic in the 22 subjects tested.
- Executive summary:
Twenty-two healthy male and female volunteers were screened and completed the study.
The material was applied under occlusion. Following a ten to fourteen day rest period challenge patches of all materials were applied under occlusion to fresh sites for 48 hours.
No reactions were observed from the 22 subjects screened.
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