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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 921-874-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N4-(3-chloro-4-fluorophenyl)-7-[(3S)-oxolan-3-yloxy]quinazoline-4,6-diamine
- EC Number:
- 921-874-8
- Cas Number:
- 314771-76-1
- Molecular formula:
- C18 H16 Cl F N4 O2
- IUPAC Name:
- N4-(3-chloro-4-fluorophenyl)-7-[(3S)-oxolan-3-yloxy]quinazoline-4,6-diamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Male, Himalayan strain rabbit were obtained from LPT Laboratory of Pharmacology and Toxicology KG, branch L
-The rats were in Initial body weight of: 2.3 kg (animal 1), 2.1 kg (animal 2) and 2.2 kg (animal 3)
-Rats were approximately: 4 months old
CONDITIONS
-Drinking water was offered ad libitum before and after the exposure period.
-Diet: ssniff® K-H V2333 (ssniff Spezialdiaten GmbH, D-59494 Soest, served as food. Feeding was available ad libitum before and after the exposure period.
- AnimalHousing:
Before and after the 4-hour exposure period, the animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm (manufacturer Dipl. Ing W. EHRET GmbH, D-16352 Schőnwalde). at a room temperature of 20 °C ± 3 °C (maximum range) and relative humidity of 55% ± 15% (maximum range).
Deviations from the maximum ranges caused for example during cleaning procedures are dealt with in SOPs
The rooms were lit (150 lux at approx. 1.5 m room height) and darkened for periods of 12 hour light/12-hour dark cycle (light 6:00 a.m. to 6:00 p.m. to 6:00 a.m.)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg/patch and animal
(3000 mg of the test substance was mixed with 3ml aqua ad iniectabilia, 1000 mg of this paste was applied per animal (500 mg test substance/animal)). - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60min; 24,48 and 72 hours
- Number of animals:
- 3 male
- Details on study design:
- As a general criteria, the body weight of all animals was measured at the beginning of the study.
The evaluation of the skin was based on grading score/scheme.
The test substance was applied to the test site and then covered with a gauze patch. The patch was held in contact with skin with non-irritating tape for the duration of the exposure period.
- Surrounding untreated skin served as a control.
- During four hours of exposure time the animals were in comfortable restrainers. No residual test substance had to be removed, as no test substance was left on the skin after removal of the patch.
During examination of the skin,the skin sites were evaluated immediately before the application of the test substance.
- After the 4-hour exposure period the patch was removed and the skin sites were evaluated.
- Scores were taken 60 minutes, 24, 48 and 72 hours after the patch removal.
- Based on most recent guidelines the skin reactions are monitored until the changes observed have completely subsided.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60min
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60min
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions none of three rabbits exposed for 4 hours to 500 mg CDBA0578BS/patch and animal (semi-occlusive
conditionl showed any substance-related lesions.
There were no systemic intolerance reactions.
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.
