Registration Dossier
Registration Dossier
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: 284-664-9 | CAS number: 84961-74-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-08 to 2012-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The scientific literature (eg ref 1) indicates that for surfactant materials such as Benzenesulfonic acid, 4-C10-C13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1), the LLNA study can give false positive results. Therefore, a Guinea Pig Maximisation Test was undertaken rather than the LLNA.
Ref 1: Ball et al (2011). Evaluating the sensitization potential of surfactants: Integrating data from the local lymph node assay, guinea pig maximization test, and in vitro methods in a weight-of-evidence approach
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
- EC Number:
- 284-664-9
- EC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
- Cas Number:
- 84961-74-0
- Molecular formula:
- N/A
- IUPAC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1)
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine (1:1)
- Substance type: technical product (BIO-SOFT 411-E)
- Physical state: viscous liquid
- Analytical purity: 97%
- Lot/batch No.: 50148
- Expiration date of the lot/batch: 30 June 2013
- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 4 weeks
- Weight at study initiation: 237-269 g
- Housing: in groups of two or individually, in polycarbonate containers
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: isotonic sodium chloride
- Concentration / amount:
- intradermal injection of 0.5%, epicutaneous application at 20%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: isotonic sodium chloride
- Concentration / amount:
- 0.5% and 0.25% test material
- No. of animals per dose:
- 10 (5 for control)
- Details on study design:
- RANGE FINDING TESTS:
intradermal injection ( determination of Maximal Non Necrotizing Concentration: MNNC)-0.1 mL of the test material at 5, 10, 25 and 50% in isotonic sodium chloride. Necrosis was seen in all dose levels, and hence, lower concentrations were tested: 0.2, 0.5, 1 and 2%
topical application
1.determination of the Pre-Maximal Non Irritant Concentration (Pre-MNIC): 10, 20, 50, 100% in distilled water, 24 h with occlusive dressing. Excessive irritation was seen, and therefore, two more animals were tested at 7.5% and 5% in water.
2. determination of the Maximal Non Irritant Concentration: 1, 2, 5 and 10% in distilled water
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections and one epicutaneous application
- TEST GROUPS:
intradermal- 1. 50% FCA in vehicle, 2. TM (Test Material) at 0.5% in vehicle, 3. FCA 50% v/v, 50% TM (1% v/v) in vehicle
epicutaneous- induction of local irritation at the testing site with 10% sodium lauryl sulphate in thick vaseline (Day 6)
Day 7: 0.5 mL TM at 20% in distilled water, occlusive dressing for 48 hours
-CONTROL GROUP:
intradermal- 1. 50% FCA in vehicle, 2. vehicle, 3. FCA at 50% in vehicle (equal volumes)
epicutaneous- 0.5 mL distilled water
- Site: scapular zone
- Frequency of applications: day 0 (intradermal) and day 7 (epicutaneous)
- Duration: 0-9 days
B. CHALLENGE EXPOSURE
- Exposure period: 24 h (occlusive dressing)
- Test groups: 0.5% and 0.25% test material
- Site: dorso-lumbar area - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde showed positive results, i.e. it exerted allergenic reactions on the guinea pigs tested.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- 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:
- 0.25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- 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:
- negative control
- Dose level:
- 0.25%
- 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:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 6.25%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 6.25%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
MNNC determination: no necrosis was seen at 0.5% and below.
Pre MNIC determination: severe and moderate erythema was seen at doses 7.5 -100%. Slight to moderate erythema was seen at 5%.
MNIC determination: slight to moderate erythema was seen at 2%, and moderate erythema at 1%. No reaction was seen at 0.5 and 0.25%.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this result, benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) is not a dermal sensitizer.
- Executive summary:
In a dermal sensitization study with BIO-SOFT 411-E and hence benzenesulfonic acid, 4 -C10 -13 -sec-alkyl derivs.-, compd. with 2 -propanamine (1:1) (97% purity) in isotonic sodium chloride, ten young adult Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligmann according to OECD Guideline 406. α-Hexylcinnamaldehyde was used as a positive control material.
No cutaneous reaction attributable to allergy was recorded in animals from the treated group after the challenge phase, with the test item at 0.25% and 0.5%. No cutaneous intolerance reaction was recorded in animals from the negative control group after the challenge phase, on the treated area with the test item at 0.25% and 0.5%.
In this study, the test item is not a dermal sensitizer.
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.
