Registration Dossier
Registration Dossier
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: 425-120-4 | CAS number: 83847-14-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 February - 12 February 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 425-120-4
- EC Name:
- -
- Cas Number:
- 83847-14-7
- Molecular formula:
- C23H23NO5
- IUPAC Name:
- 4-cyanophenyl 4-{[6-(prop-2-enoyloxy)hexyl]oxy}benzoate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kißlegg
- Age at study initiation: about 22 weeks
- Weight at study initiation: 3.01 - 3.91 kg
- Housing: separately in special rabbit cages (manufacturer: Becker; type
K99/30 KU, floor area about 5400 cm2
- Diet: ad libitum (Altromin Standard Diet TPF(R) 2113, pellets)
- Water: ad libitum (tap water)
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22
- Humidity (%): 54 to 75
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin alterations, behaviour, and general conditions were observed 1 hour, 24, 48, 72 hours after patch removal, and then daily up to day 8.
Bodey weight was recorded on day 1 and on days 5 and 8. - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: self-adhesive fabric
REMOVAL OF TEST SUBSTANCE
- Washing: any test material left was wiped off
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
Skin alterations, behaviour, and general conditions were observed 1 hour, 24, 48, 72 hours after patch removal, and then daily up to day 8.
Bodey weight was recorded on day 1 and on days 5 and 8.
SCORING SYSTEM:
- Method of calculation: according to DRAIZE scheme and OECD Guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- - Other adverse local effects:
no
- Other adverse systemic effects: no
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, no signs of irritation were seen. Thus, the test item is not considered to be irritating to rabbits' skin.
- Executive summary:
To investigate the potential for primary skin irritation, 0.5 g of the test material were mixed with a few drops of Aqua pro injectione to ensure good contact to the skin, spread onto patches, and then applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for another 7 days.
The individual mean scores (considering readings 24, 48, and 72 hours after patch removal) of each animal were 0 for erythema and edema. Furthermore, no signs of systemic toxicity, no mortality and a normal body weight gain were observed.
Under the conditions of the present study, the test item is not considered to be 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.
