Registration Dossier

Diss Factsheets

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:
1996
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

Constituent 1
Reference substance name:
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
IUPAC Name:
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
Constituent 2
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
Constituent 3
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

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  
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 0 10 00 10 00 ±
 349 E0 00 0 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.

Categories Display