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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:
1981
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

Constituent 1
Chemical structure
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

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