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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 604-568-6 | CAS number: 147118-40-9
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The studies were carried out in 2010.
Test material
- Reference substance name:
- Methyl(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate
- Cas Number:
- 147118-40-9
- Molecular formula:
- C23H30FN3O6S
- IUPAC Name:
- Methyl(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: LAB-ÁLL Bt. Budapest, Hungary- Weight at study initiation: 342-360 g - Housing: 2-3 animals in 42x42x19 cm macrolon cages- Diet (e.g. ad libitum): ad libitum, CuniFort Intensive Rabbit Diet Mixture (Tendre Ltd.)- Water (e.g. ad libitum): ad libitum, potable water containing 50 mg/100 ml Ascorbic acid.- Acclimation period: 20 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 3 °C- Humidity (%): 30-70 %- Rate of air exchange: No data.- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: methyl cellulose (1%)
- Concentration / amount:
- Inradermal Induction Exposure (Main Study I): 1 % of the test item homogenized in methyl cellulose (1%)Control group: Vehicle only.Dermal Induction Exposure (Main Study II): 25% of the test item homogenized in methyl cellulose (1%)Control group: Vehicle only. Challenge Exposure (Main Study III): 10 % of the test item homogenized in methyl cellulose (1%) both in the test and control group.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: methyl cellulose (1%)
- Concentration / amount:
- Inradermal Induction Exposure (Main Study I): 1 % of the test item homogenized in methyl cellulose (1%)Control group: Vehicle only.Dermal Induction Exposure (Main Study II): 25% of the test item homogenized in methyl cellulose (1%)Control group: Vehicle only. Challenge Exposure (Main Study III): 10 % of the test item homogenized in methyl cellulose (1%) both in the test and control group.
- No. of animals per dose:
- In the range finding study: 2 animals / 2 concentrations (2 concentrations in 1 animal: one on the right side and the other on the left side)Main study: test groups - 10 animals control group - 5 animals
- Details on study design:
- 10 test animals were subjected to sensitization procedures in a two stage operation, i.e. intradermal treatment and a topical application.The test item was used in concentration of 1 % for intradermal injections and in concentration of 25 % for dermal sensitization treatment. Two weeks following the last induction exposure, a challenge dose (at concentration of 10%) was administered. Challenge was performed by dermal application of the test item.
- Challenge controls:
- 5 control guinea pigs were simultaneously exposed to vehicle during the sensitization phase and they were treated with the test item (at concentration of 10 %) only in the case of challenge.
Results and discussion
- Positive control results:
- Incidence RatePositive response was observed in 60 % of the test animals after challenge with the test item. Positive response was observable in one control animal (20 %) 24 hours after the patch removal. Intensity of Sensitisation ResponseChallenge with the test item elicited discrete erythema in six out of ten animals (60%) on the skin surface of previously sensitized guinea pigs. The mean of the scores were 0.6 and 0.0 according to the 24 and 48 hour observations.In the control group the mean of the scores were 0.2 and 0.0.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no visible change
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results the substance should be classified in the EU as: Xi, R43 - May cause sensitisation by skin contact, and Skin Sens 1, H 317. May cause an allergic skin reaction.
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.
