Registration Dossier
Registration Dossier
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EC number: 307-055-2 | CAS number: 97489-15-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline study, non-GLP study but conducted according to valid scientific standards still acceptable compared to nowadays existing guidelines. Study sufficiently reported and documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 10 i.c. injections within 14 days of first induction phase; 2 challenge treatments
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo study data were obtained in studies performed before any in vitro sensitization tests had been validated and accepted for regulatory purposes
Test material
- Reference substance name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- EC Number:
- 307-055-2
- EC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Cas Number:
- 97489-15-1
- Molecular formula:
- H3C-(CH2)m-CH-(SO3Na)-(CH2)n-CH3
- IUPAC Name:
- Sulfonic acids, C14-17-sec-alkane, sodium salts
- Reference substance name:
- 307-055-1
- IUPAC Name:
- 307-055-1
- Reference substance name:
- Hostapur SAS 60
- IUPAC Name:
- Hostapur SAS 60
- Details on test material:
- - Name of test material (as cited in study report): Hostapur SAS 60
- Physical state: pasty
- Analytical purity: 60%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: 60% Hostapur SAS 93, water
- Isomers composition: n.a.
- Purity test date: 60%
- Lot/batch No.: no data
- Expiration date of the lot/batch: 1976
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: no data
- Other:
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: in house breeding
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- No. of animals per dose:
- 6 animals for irritation screen
15 animals for main study - Details on study design:
- RANGE FINDING TESTS: Yes, irritation screen with 6 animals
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 intradermal injections
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Concentrations: 0.0 mL of a solution of 500 mg Hostapur SAS in 10 mL Freund`s complete adjuvans for intradermal induction
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Concentrations: 5% in water
- Evaluation (hr after challenge): 24 and 48 hours after each challenge treatment
- Challenge controls:
- Yes
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: not sensitizing
- Executive summary:
Sec-alkane sulfonate-sodium salts SAS (60%) was examined for its capacity to cause contact allergy by the maximization test according to Magnusson and Kligman with guinea pigs. Based on a screening study using groups of 6 male guinea pigs the highest non-irritating concentration of sec-alkane sulfonate-sodium salts SAS (60%) was established to be 5% in water. In the main study 15 male guinea pigs were used. Induction exposure included 10 intracutaneous injections of 0.05 mL of a solution of 500 mg sec-alkane sulfonate-sodium salts SAS (60%) in 10 mL of Freund`s complete adjuvant. Challenge was made 14 days after the last injection using 0.1 mL of sec-alkane sulfonate-sodium salts SAS (60%) at 5% test concentration. Readings performed 24 and 48 hours after the challenge treatment revealed no signs of skin reactions (sensitization incidence = 0%). Additionally, also a second challenge treatment using the same test conditions like in the first challenge revealed no signs of skin reactions (sensitization incidence = 0%). Thus it was concluded that sec-alkane sulfonate-sodium salts SAS is not a skin sensitizer.
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