Registration Dossier
Registration Dossier
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EC number: 225-948-4 | CAS number: 5165-97-9
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:
- January 31 - March 3, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study conducted to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
- IUPAC Name:
- 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
- Reference substance name:
- Ammonium 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonate
- EC Number:
- 421-680-9
- EC Name:
- Ammonium 2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonate
- IUPAC Name:
- 421-680-9
- Reference substance name:
- 58374-69-9
- EC Number:
- 611-646-3
- Cas Number:
- 58374-69-9
- IUPAC Name:
- 58374-69-9
- Details on test material:
- - Name of test material (as cited in study report): OS 114454
- Molecular formula (if other than submission substance): C7H13NO4S.H4N
- Molecular weight (if other than submission substance): 225.29
- Smiles notation (if other than submission substance): [NH4+].O=S(=O)(O)CC(C)(C)/N=C(\[O-])C=C
- InChl (if other than submission substance): InChI=1/C7H13NO4S.H3N/c1-4-6(9)8-7(2,3)5-13(10,11)12;/h4H,1,5H2,2-3H3,(H,8,9)(H,10,11,12);1H3
- Substance type: organic
- Physical state: liquid
- Analytical purity: 50% aqueous solution
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date:not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, UK
- Age at study initiation: approximately 7 to 8 weeks
- Weight at study initiation: 489-599 g
- Housing: groups of 5 in suspended metal cages with wire mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21°C
- Humidity (%): 30-37%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 31/01/1996 To: 03/03/1996
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal injection: 20% v/v in water for irrigation
Topical appliaction: 20% v/v in distilled water
Challenge application: 10% and 5% v/v in distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal injection: 20% v/v in water for irrigation
Topical appliaction: 20% v/v in distilled water
Challenge application: 10% and 5% v/v in distilled water
- No. of animals per dose:
- 10 test and 5 control
- Details on study design:
- RANGE FINDING TEST: Animals were pre-treated with an inter-dermal injection Freund’s complete adjuvant, 50:50 with water for irrigation, approximately 1 week prior to the start of the preliminary investigations.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: inter-dermal: 3 pairs of injections and 1 topical application
- Exposure period: topical exposure of 48 hours 1 week after inter-dermal exposure
- Test groups: 1 group of 10 animals
- Control group: 1 group of 5 animals
- Site: scapular
- Frequency of applications: 1 week
- Duration: 48 hours
- Concentrations: 20% v/v in water
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after topical induction
- Exposure period: 24 hours
- Test groups: 1 group of 10 animals
- Control group: 1 group of 5 animals
- Site: left flank
- Concentrations: 5% v/v
- Evaluation (hr after challenge): 24, 48 and 72 hours after removal of the challenge application - Challenge controls:
- Yes, treated in same way as test animals.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Localised dermal irritation, anterior site
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: Localised dermal irritation, anterior site.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Erythema, anterior site
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Erythema, anterior site.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Localised irritation, anterior site
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: Localised irritation, anterior site.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Erythema, anterior site
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Erythema, anterior site.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- Localised irritation, anterior site
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: Localised irritation, anterior site.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Erythema, anterior site
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Erythema, anterior site.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
| Guinea Pig Number | Erythema Oedema |
Score | Results Positive (+) Negative (-) Inconclusive (±) |
|||||
| 24 hours | 48 hours | 72 hours | ||||||
| A | P | A | P | A | P | |||
| 340 | E O |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
| 341 | EO | 00 | 00 | 00 | 00 | 00 | 00 | - |
| 342 | EO | 00 | 00 | 00 | 00 | 00 | 00 | - |
| 343 | EO | 00 | 00 | 00 | 00 | 00 | 00 | - |
| 344 | EO | 00 | 00 | 00 | 00 | 00 | 00 | - |
| 345 | EO | 00 | 00 | 00 | 00 | 00 | 00 | - |
| 346 | EO | 00 | 00 | 00 | 00 | 00 | 00 | - |
| 347 | EO | 00 | 00 | 00 | 00 | 00 | 00 | - |
| 348 | EO | 10 | 00 | 10 | 00 | 10 | 00 | ± |
| 349 | E0 | 00 | 00 | 00 | 00 | 00 | 00 | - |
Control Animals |
||||||||
| 335 | EO | 00 | 00 | 00 | 00 | 00 | 00 | |
| 336 | EO | 00 | 00 | 00 | 00 | 00 | 00 | |
| 337 | EO | 00 | 00 | 00 | 00 | 00 | 00 | |
| 338 | EO | L10 | 00 | L10 | 00 | L10 | 00 | |
| 339 | EO | 00 | 00 | 00 | 00 | 00 | 00 | |
L: Localised dermal irritation
A: Anteror site, exposed to 10% v/v in distilled water
P: Posterior site, exposed to 5% v/v in distilled water
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the test substance did not produce evidence of skin sensitisation (delayed contct hypersensitivity) in nine of the ten test animals. The remaining animal gave an inconclusive response.
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