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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-707-9 | CAS number: 162353-70-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 16 Dec 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see “remarks”
- Remarks:
- GLP-Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the government of the United Kingdom
Test material
- Reference substance name:
- 147256-33-5
- EC Number:
- 604-580-1
- Cas Number:
- 147256-33-5
- IUPAC Name:
- 147256-33-5
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain (as specified by author): Hsdlf:NZW
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.40-2.84 kg
- Housing: individually in suspended cages with environmental enrichment items
- Diet: ad libitum, 2930 Teklad Global Rabbit diet (Harlan Laboratories Ltd., Oxon, UK)
- Water : ad libitum, mains drinking water
- Acclimatisation: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: immediately after patch removal, 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of the back of the rabbit
- Type of wrap if used: cotton gauze patch secured in position with a strip of surgical adhesive tape, the trunk of the rabbit was wrapped in an elasticated corset during exposure
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, any residual test item was removed by gentle swabbing with cotton wool saked in distilled water
- Time after start of exposure: 4h
SCORING SYSTEM: according to Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal: #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal: #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all three animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was noted at one treated skin site at the 24 and 48 h reading time points. Effects were fully reversible within 72 h.
- Other effects:
- All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Erythema score
Animal Number |
1 h |
1 day |
2 days |
3 days |
71416 |
0 |
0 |
0 |
0 |
71453 |
0 |
1 |
1 |
0 |
71454 |
0 |
0 |
0 |
0 |
Table 2: Edema score
Animal Number |
1 h |
1 day |
2 days |
3 days |
71416 |
0 |
0 |
0 |
0 |
71453 |
0 |
0 |
0 |
0 |
71454 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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.
