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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 230-907-9 | CAS number: 7365-45-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 01, 2002 - May 19,2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- yes
- Remarks:
- The body weight at the start of the study was outside the target range of 2.50-5.50 kg. This deviation did not influence the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid
- EC Number:
- 230-907-9
- EC Name:
- 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid
- Cas Number:
- 7365-45-9
- Molecular formula:
- C8H18N2O4S
- IUPAC Name:
- 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid
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 Wiga GmbH, Kißlegg
- Age at study initiation: ~15 weeks
- Weight at study initiation: 2.05 kg (range from 2.00 to 2.13)
- Housing: separately in special rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 19
- Humidity (%): 45 to 72
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: day 1 To: day 8
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test material mixed with some drops of Aqua pro injectione to ensure good contact
- Duration of treatment / exposure:
- 4 hour period under semiocclusive conditions
- Observation period:
- 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100 %
- Type of wrap: Fixomull® stretch, Beiersdorf
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: after 4 hours
SCORING SYSTEM: Draize (1959)
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:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed at the treated areas.
- Other effects:
- - Other adverse systemic effects: No signs of clinical toxicity were detected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin irritating potential could be detected. The test material can be regarded as non irritant.
- Executive summary:
The test performed in accordance with OECD TG 404. 0.5 g of the test material mixed with some drops aqua pro injectione were spread onto 6 cm² patches and applied to the intact skin of 3 previously shaven rabbits (females) for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.
Under the conditions of the present study, no signs of toxicity were seen.
Evaluation of each animal:
Mean score (24h, 48h, 72h)
Maximum value (24h, 48h, or, 72h)
Animal No.
31
32
33
31
32
33
Erythema
0.0
0.0
0.0
0
0
0
Edema
0.0
0.0
0.0
0
0
0
No skin irritating potential could be detected. The test material should not be classified as a skin irritant.
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.
