Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-574-2 | CAS number: 68890-66-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 404 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
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:
- Octopirox
- IUPAC Name:
- Octopirox
- Reference substance name:
- Piroctone olamine
- IUPAC Name:
- Piroctone olamine
- Reference substance name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- EC Number:
- 272-574-2
- EC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Cas Number:
- 68890-66-4
- Molecular formula:
- C14H23NO2.C2H7NO
- IUPAC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Reference substance name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
- IUPAC Name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
- Details on test material:
- - Name of test material (as cited in study report): Octopirox
- Substance type: solid
- Physical state: white to slightly yellowish white powder
- Analytical purity: 100 %
- Lot/batch No.: Batch E 141
- Production date: Nov 1985
- Stability under test conditions:
- Storage condition of test material: darkness at approx. 22 °C in a fume cupboard
- melting point: 130-135 °C decomp.
- pH in water : 8.5 - 10 (suspension of 10 g/L in water at 20°C)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.7 - 3.1 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1986-10-28 To: 1986-11-04
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 mL isotonic saline - Duration of treatment / exposure:
- 4 hrs
Then test substance was removed from the skin with warm tap water - Observation period:
- 30 - 60 min. after removal of the patches
24, 48 and 72 hrs after removal of the patches
7 days after removal of the patches - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The moistened substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skinarea (ca. 25 cm2) and then covered with a semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure: 4 hrs
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 (lesion in depth).........4
Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72 h
- Score:
- 2.7
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72 h
- Score:
- 2.3
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 h / 48h /72 h
- Score:
- 2.7
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72 h
- Score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72 h
- Score:
- 0.1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- see above "irritation / corrosion results"
Any other information on results incl. tables
| Time after removal of the patch | 30 - 60 min |
24 h | 48 h | 72 h | 7 d | ||||||||||
| Animal no. | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
| Erythema and eschar formation | 1 | 2 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 0 | 0 | 0 |
| Oedema formation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Surface of the skin - dry, brittle | x | x | |||||||||||||
| Separation of fine scales | x | ||||||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testing of Octopirox for primary dermal irritation in the rabbit showed that, based on the criteria laid down in the Directive 83/467/EEC, the substance has to be labelled as irritant (Xi) with the designation R38 - irritates the skin.
- Executive summary:
Octopirox was tested for skin irritation / corrosion according to OECD test guideline 404 in rabbits. Each animal was treated with 500 mg Octopirox moistened with 0.4 mL isotonic saline and covered by semi-occlusive bandage. The exposure period was 4 hours. After the exposure period all remnants were carefully removed from the skin with warm tap water. Readings were performed 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because effects were still present after 72 hours, additional readings were performed after 7 days. One hour to 72 hours after removal of the patches the treated skin exhibited very slight to moderately severe erythema. Seven days after application all signs of irritation were reversible. Based on this result, technically pure Octopirox must be considered as irritating to skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
