Registration Dossier
Registration Dossier
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EC number: 216-341-5 | CAS number: 1561-92-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study from 1981, pre-dating OECD protocols and GLP. Lees weel documented than more recent studies, but sufficient for risk assessment and C&L
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- animal model: rabbit, 6 male
mode of application: test substance dissolved in water; under occlusion; 2 patches per animal (after shaving , abraded and non-abraded patch.
Observation: 24 and 2 hours after application
Rating - GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 2-methylprop-2-ene-1-sulphonate
- EC Number:
- 216-341-5
- EC Name:
- Sodium 2-methylprop-2-ene-1-sulphonate
- Cas Number:
- 1561-92-8
- Molecular formula:
- C4H8O3S.Na
- IUPAC Name:
- sodium 2-methylprop-2-ene-1-sulfonate
- Test material form:
- other: solution
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, 4540 Lengerich.
- Age at study initiation: 11- 17 weeeks
- Weight at study initiation: 2.46-3.02 kg
- Housing: Individual cages, straw bedding Die Versuchstiere wurden einzeln in Stahlkafigen auf Lochblechböden über mit Einstreu gefüllten Kotwannen in klimatisierten Raumen unter konven- tionellen Bedingungen gehalten (10 x Luftwechsel/ Stunde, Raumtemperatur 2 0 - 2 3 °C, relative Luftfeuchtigkeit von 40 - 70 %, 12 Stunden Tag- Nacht-Rhythmus). Einstreu wurde so oft wie für die Hygiene notwendig gewechselt. Die Wasserflaschen wurden wöchentlich gereinigt.
- Diet (e.g. ad libitum): at lib.
- Water (e.g. ad libitum): at lib.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Sept To:Oct 1981 (dates not given)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one patch shaved, one patch shaved and abraded
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg, wetted-out with aqua dest.
- Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 72 hrs
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 * 2.5 cm
- % coverage: 100
- Type of wrap if used: self-adhesive plastic foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not. residues removed with tissue
- Time after start of exposure: 24
SCORING SYSTEM: Draize: redness 0-4; edema 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- ca. 4
- Max. score:
- 48
- Reversibility:
- fully reversible within: 71
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 48
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- ca. 6
- Max. score:
- 48
- Reversibility:
- fully reversible within: 72
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 48
- Irritant / corrosive response data:
- 24 hrs: grade 1 redness in 2/6 animals; grade 1 edema in 3/6 animals
72 hrs: no redness or edema remaining - Other effects:
- none
Any other information on results incl. tables
Animal nr |
Weight |
Time |
Redness |
edema |
||||
abraded |
intact |
abraded |
intact |
|||||
7 |
2.87 |
24 |
1 |
1 |
1 |
1 |
||
72 |
0 |
0 |
0 |
0 |
||||
8 |
2.58 |
24 |
1 |
1 |
1 |
1 |
||
72 |
0 |
0 |
0 |
0 |
||||
9 |
2.46 |
24 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||||
10 |
3.02 |
24 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||||
11 |
2.66 |
24 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||||
12 |
2.88 |
24 |
0 |
0 |
1 |
1 |
||
72 |
0 |
0 |
0 |
0 |
||||
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- slightly irritating but insufficient for classification
- Executive summary:
Sodium methallyl sulphonate, 500 mg humified, was applied to both abraded and intact skin on 6 young male New Zealand White rabbits on patches of 2.5 cm * 2.5 cm. After 24 hrs, the occlusive bandaging was removed, After 24 hrs. minimal to slight redness was observed in 2/6 animals, and minimal to slight edema in 3/6 animals. After 72 hrs no effects were visible. Substance need not be classified for irritative effects
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