Registration Dossier
Registration Dossier
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EC number: 204-809-1 | CAS number: 126-86-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4,7,9-tetramethyldec-5-yne-4,7-diol
- EC Number:
- 204-809-1
- EC Name:
- 2,4,7,9-tetramethyldec-5-yne-4,7-diol
- Cas Number:
- 126-86-3
- Molecular formula:
- C14 H26 O2
- IUPAC Name:
- 2,4,7,9-tetramethyldec-5-yne-4,7-diol
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- The test article was weighed and 0.5 g was moistened with distilled water (made pasty) to ensure
good contact with the skin.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100 %
- Type of wrap if used: patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with destilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION
No erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight erythema (barely perceptible) . . . . . . . . . . . . . . . . . . . . 1
Well defined erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate to severe erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
OEDEMA FORMATION
No oedema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight oedema (barely perceptible) . . . . . . . . . . . . . . . . . . . . . . 1
Slight oedema (edges of area well defined by
definiteraising) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate oedema (raised approximately 1.0 mm) . . . . . . . . . . . . . 3
Severe oedema (raised more than 1.0 mm and
ex tending beyond area of exposure) . . . . . . . . . . . . . . . . . . . . . . . . 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: mildly irritating
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Erythema, slight at 30 - 60 minutes after patch removal, was absent to slight at 24 hours and absent at 48 and 72 hours. Edema, was absent at all observation intervals. There were no abnormal physical signs noted during the observation period.Primary Irritation Index of 0.17 (mildly irritating) when applied to the intact skin as a paste.
Any other information on results incl. tables
| Irritation parameter | Basis | Time point | Score |
| erythema score | animal #1 D9878/M | 1 hour | 1 |
| erythema score | animal #1 D9878/M | 24 hours | 0 |
| erythema score | animal #1 D9878/M | 48 hours | 0 |
| erythema score | animal #1 D9878/M | 72 hours | 0 |
| edema score | animal #1 D9878/M | 1 hour | 0 |
| edema score | animal #1 D9878/M | 24 hours | 0 |
| edema score | animal #1 D9878/M | 48 hours | 0 |
| edema score | animal #1 D9878/M | 72 hours | 0 |
| erythema score | animal #2 D9879/M | 1 hour | 1 |
| erythema score | animal #2 D9879/M | 24 hours | 1 |
| erythema score | animal #2 D9879/M | 48 hours | 0 |
| erythema score | animal #2 D9879/M | 72 hours | 0 |
| edema score | animal #2 D9879/M | 1 hour | 0 |
| edema score | animal #2 D9879/M | 24 hours | 0 |
| edema score | animal #2 D9879/M | 48 hours | 0 |
| edema score | animal #2 D9879/M | 72 hours | 0 |
| erythema score | animal #3 D9880/M | 1 hour | 1 |
| erythema score | animal #3 D9880/M | 24 hours | 1 |
| erythema score | animal #3 D9880/M | 48 hours | 0 |
| erythema score | animal #3 D9880/M | 72 hours | 0 |
| edema score | animal #3 D9880/M | 1 hour | 0 |
| edema score | animal #3 D9880/M | 24 hours | 0 |
| edema score | animal #3 D9880/M | 48 hours | 0 |
| edema score | animal #3 D9880/M | 72 hours | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article is a mild irritant but not corrosive.
- Executive summary:
Erythema, slight at 30 - 60 minutes after patch removal, was
absent to slight at 24 hours and absent at 48 and 72 hours.
Edema, was absent at all observation intervals. There were
no abnormal physical signs noted during the observation
period.Primary Irritation Index of 0.17 (mildly irritating)
when applied to the intact skin as a paste.
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