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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-402-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from Oct 2003 till May 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive sealing of the application site
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Nederland GLP
Test material
- Reference substance name:
- Dimethyl [3-[(hydroxymethyl)amino]-3-oxopropyl]phosphonate
- EC Number:
- 243-528-9
- EC Name:
- Dimethyl [3-[(hydroxymethyl)amino]-3-oxopropyl]phosphonate
- Cas Number:
- 20120-33-6
- Molecular formula:
- C6H14NO5P
- IUPAC Name:
- dimethyl [3-[(hydroxymethyl)amino]-3-oxopropyl]phosphonate
- Reference substance name:
- Dimethyl (3-amino-3-oxopropyl)phosphonate
- EC Number:
- 219-765-9
- EC Name:
- Dimethyl (3-amino-3-oxopropyl)phosphonate
- Cas Number:
- 2526-69-4
- Molecular formula:
- C5H12NO4P
- IUPAC Name:
- dimethyl (3-amino-3-oxopropyl)phosphonate
- Test material form:
- liquid: viscous
- Details on test material:
- technical product
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 137244407
- Expiration date of the lot/batch: July, 2004
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding facility JRF
- Weight at study initiation: 2.14 -2.18 kg
- Housing: Individually, stainless steel wire meshed cages
- Diet: Rabbit pellet diet from Amrut feeds by Pranav Agro; ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 63-64
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 h
IN-LIFE DATES: From: 29 Jan 2004 To: 3 Feb 2004
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml of undiluted Aflammit KWB
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Dorso lumbar region at contralateral site
- % coverage: 6cm²
- Type of wrap if used: Meditape 330 hypo-allergic surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton soaked in distilled water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- No clinical signs related to treatment other than dermal reactions were observed during the experimental period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is classified as not irritating to the skin of rabbits.
- Executive summary:
Skin irritation study was carried out with Aflammit KWB according to OECD 404 guideline in NZW rabbit (Semi-occlusion). Under the conditions of this experiment, test substance was found to cause a primary irritation score of 0.00 when applied to healthy intact rabbit skin. No clinical signs related to treatment other than dermal reactions were observed during the experimental period. Based on the study results the test article is classified as not irritating to the skin of rabbits.
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.
