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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 604-604-0 | CAS number: 147770-06-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec. 15, 1998 - Jan. 15, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study is from 1998
Test material
- Reference substance name:
- 2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester
- EC Number:
- 604-604-0
- Cas Number:
- 147770-06-7
- Molecular formula:
- C29 H40 N2 O4
- IUPAC Name:
- 2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 10/5 (test/control) Hsd Poe : DH - guinea pigs (Full-Barrier) , Sex: female,
nulliparous, nonpregnant, body weight at the commencement of the study
302 - 315 g, age approx. 4-5 weeks.
The animals were derived from a controlled full barrier maintained breeding
system (spf).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals
were bred for experimental purposes.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Day 0:
Injectionvolume: 0.1ml
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonie saline
Injection 2: Test item 20%
Injection 3: Test item at a concentration of 10% (V/V) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonie saline.
Day 7:
A pateh was fully loaded with the test item, applied to the test area and held
in contaet by an occlusive dressing for 48 hours - Day(s)/duration:
- Day 0: intradermal;
Day 7: topical application, duration 48 hours - Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Day 0:
Injectionvolume: 0.1 ml
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonie saline
Injection 2: Cottonseed Oil
Injection 3: Cottonseed Oil at a concentration of 50% (VN) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonie saline.
Day 7:
A patch was fully loaded with Cottonseed Oil and applied to the test area
and held in contact by an occlusive dressing for 48 hours. - Day(s)/duration:
- Day 0 intradermal
Day 7 : topical application duration 48 hours - Adequacy of induction:
- other: control
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance (left), cotton seed oil (right)
- Day(s)/duration:
- Day 20/ 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10/5 (test/control)
- Details on study design:
- RANGE FINDING TESTS: 3 animals topical treated with test item, no signs of irration were recorded after a contact period of 24 h.
- Challenge controls:
- A patch loaded with the test item was applied to the left flank of the animals
and, a patch loaded with Cottonseed Oil to the right flank (intraspecifie control), respectively. The patches were held in contact by an occlusive dressing for 24 hours. At the end of the chaIIenge skin was cleaned with the aid of moistened gauze patches. - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole.
Results and discussion
- Positive control results:
- conducted in April/May 1998, concentrations: 2% induction -1 phase, 25% induction-2 phase, 15% in challenge, use of substance as positive control, having mild to moderate sensitizer properties. The study was considered valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% test item Intradermal
100 % test item Topical Application
100% test item Challenge - No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% Cottonseed Oil Intradermal
100 % Cottonseed Oil Topical Application
100% test item Challenge - No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% test item Intradermal
100 % test item Topical Application
100% test item Challenge - No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% Cottonseed Oil Intradermal
100 % Cottonseed Oil Topical Application
100% test item Challenge - No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. to CLP
- Conclusions:
- Considering the reported data of this sensitization test it can be stated that
the test item AGEE 623 AMIDESTER caused no reactions identified as sensitization.
According to EEC criteria for classification (93/21/EEC) no labelling is necessary
as the sensitization rate was below 30%. - Executive summary:
During the induction phase the guinea pigs (10 test group, 5 control group
all females, strain: Hsd Poc:DH) were intradermally injected with a 20%
suspension of AGEE 623 AMID ESTER and topically treated with 100 %
AGEE 623 AMIDESTER. After a latency of 14 days - to allow a potential
reaction of the immune system - the animals were challenged with the test
item on the flank. The grade of skin reactions was compared to control animals,
which were treated with the vehicle ( cotton seed oil) during the induction
phase and, during challenge phase with the test item, respectively.
The sensitization rate after application of AGEE 623 AMIDESTER was
0 %. Under the test conditions described below the test item showed no sensitizing
properties. No other signs of toxicity were observed. All animals
showed normal food intake and weight gain.
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.
