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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 298-265-2 | CAS number: 93783-70-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from November 15 to 22, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Source study has reliablity 1. Details on the read across are attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.3, 2.7, 3.3 kg
- Housing: one rabbit per cage (Drahtkäfige Typ III - hoch)
- Pellet: Holzgranulat Typ S 8/15 (Firma Sniff, Soest)
- Diet: ca. 100 - 120 g per animal per day of Sniff K 4 (Sniff Spezialdiäten GmbH, Soest/Westfallen)
- Water: ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: ca. 50 %
- Air changes: ca. 10 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours (ca. 27 Watt/m2)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl
- pH: 0.5 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Application of the test item on Hansamed - Wundpflaster "Hypoallergen" Beisedorf n. 2342
- Coverage: Fixomull - Stretch klebevlies, Beisedorf n. 2039)
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize grade
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction
Any other information on results incl. tables
| animal n. | weight | sex | 1hour | 24 hours | 48 hours | 72 hours | 7 days | 14 days | ||||||
| E | O | E | O | E | O | E | O | E | O | E | O | |||
| T54 | 3.3 kg | female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| T41 | 2.7 kg | female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| S13 | 3.3 kg | female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
E = erythema, O = oedema
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant.
- Executive summary:
Method
The substance was tested according to OECD guideline 404, using 3 females of albino rabbit.
Results
No skin effects were noted during the 7 days of observation after application.
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.
