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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 245-224-1 | CAS number: 22794-26-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- see deviations; impact discussed in conclusion
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no positive control was provided; too few animals (10 vs. 20 in case of no sensitisation classification)
- GLP compliance:
- no
- Remarks:
- audit performed
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to REACH Regulation, no in vivo assay should be performed when it is possible to conclude with the available studies or with in vitro/ in chemico methods. A Magnusson and Kligman assay has been carried out in 1981, which is robust enough to support a non classification of the test item. Therefore, no further testing has been testing, and that's why no LLNA assay has been performed.
Test material
- Reference substance name:
- Dodecyl 5-oxo-L-prolinate
- EC Number:
- 245-224-1
- EC Name:
- Dodecyl 5-oxo-L-prolinate
- Cas Number:
- 22794-26-9
- Molecular formula:
- C17H31NO3
- IUPAC Name:
- dodecyl 5-oxo-L-prolinate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LEBEAU GAMBAIS
- Microbiological status of animals, when known: not specified
- Age at study initiation: not specified
- Weight at study initiation: 200 to 250 g
- Housing: 5 per cage
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days before treatment
- Indication of any skin lesions: no skin lesion
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22 °C
- Humidity (%): 50 to 80 %
- Air changes (per hr): 3000 m3/hour
- Photoperiod (hrs dark / hrs light): 12 hours
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 0.25 mL of product at 5% in distilled water for intradermal injection
0.5 mL of undiluted product for dermal induction - Day(s)/duration:
- J0 to J8
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 0.25ml of product
- Day(s)/duration:
- J25 (24 hours of exposure)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 per condition
- Details on study design:
- A preliminary study was performed to assess the highest non-irritant dose and established to a dilution of test item at 5% in water, 0,25 mL
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 intradermal injections and 1 topical application
- Exposure period: 48 hours
- Test groups:
- 2 intradermal injections of FCA at 50% in NaCl
- 2 intradermal injections of 0.1 mL of test item diluted at 5% in water
- 2 intradermal injections of 0.1 mL of test item at the selected concentration formulated in a 1:1 mixture (v/v) FCA/ NaCl.
- Control group:
- 2 intradermal injections of FCA at 50% in NaCl
- 2 intradermal injections of 0.1 mL of water
- Site: shoulder
- Frequency of applications: d-0: intradermal injection, d-7: topical application
- Duration: 0-7 days
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: d-25
- Exposure period: 24 hours
- Test groups: 0.25 mL of test item diluted at 5% in water
- Control group: 0.25 mL of test item diluted at 5% in water
- Evaluation (hr after challenge): T+24 hours and T+48 hours
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- n/a
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.25 ml of product
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.25 ml of product
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: No positive control
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: No positive control
Any other information on results incl. tables
At 24 hours, 5/10 showed an erythema, 1/10 showed an edema and 1/10 showed an erythema/edema, all grade 1
At 48 hours, neither erythema nor edema was observed in any animals
When compared to negative controls, 10% of treated animals were considered to show sensitization.
Please see the illustration of the results below for more details.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Laurydone has been tested according to the Magnusson & Kligman method. 10% of animal exposed to the test item have showed a positive response, which correspond to a class I : sensitizing potential very small.
Under these conditions, the test item has a very low sensitizing potential.
According to the study following TG OECD 406 (1981), test item is not classified as skin sensitizer according to CLP regulation.
The study had no positive controls and only 10 treated animals (20 required if not classifying as sensitizer). However these deviations do not impact the reliability of the conclusion because the overall sensitivity stays adequate:
- the intradermal dose was above requirements (0.25 mL vs. 0.1 mL required; concentration 5%)
- some reaction was observed, proving the test system was reactive
- only 10% animals were sensitized, this is clearly below the classification cut-off in CLP (30% for intradermal concentration > 1%), doubling the number of animals is highly unlikely to lead to reach the 30% cut-off.
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.
