Registration Dossier

Administrative data

Description of key information

protocol studies for eye and skin irritation showed slight and very rapidly and totally reversible irritation only . See robust summaries in  7.3.1 and .3.2,  

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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)
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
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

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

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: old study, predating GLP. performed in accordance with contemporary guideline. sufficient information for C&L
Qualifier:
according to
Guideline:
other: IRGL Testing Standards 1981
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: H. Fortkamp, Lengerich, DE
- Age at study initiation: 11-17 weeks
- Weight at study initiation: 2,42-2.92 kgs
- Housing: singly in steel cages with straw bedding
- 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: To: not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
approx. 0.1 ml= 0.43.6 mg
Duration of treatment / exposure:
single application
Observation period (in vivo):
2 hra, 1,2,3,7 and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
animal as its own control - left eye instilled, right eye untreated
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 2 hours post application
Score:
ca. 7.83
Max. score:
110
Reversibility:
fully reversible within: 2 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 day
Score:
ca. 1
Max. score:
110
Reversibility:
fully reversible within: 1 day
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 2 , 3, 4, 7 days
Score:
ca. 0
Max. score:
110
Reversibility:
other: fully reversed
Irritant / corrosive response data:
2 hours post application: hyperaemia in all 6 anumals and minor ocular secretion. all animals slicht chemosis, slicht cornea haze in one animal.
afteron day hyperaemia in 3/6 animals;
day 3 and beyond no signs of ocular irritation
Other effects:
None

   
   
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not an eye irritant
Executive summary:

sodium methallyl sulfonate was tested for eye irritancy in 6 male albino rabbits. after installation if about half a milligram, redness of the coniunctivae was observed in 6 of the animals, and a hazy cornea in one. On dday two , redness was still visible in 3 animals, on day 3 and beyond no signs of eye irritation were observed, The substance is slightly irritating to the eyes, but need not be classified in view of the slight character of the lesions and the rapid and total reversibility.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
protocol study

Justification for selection of eye irritation endpoint:
protocol study

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

protocol studies for eye and skin irritation showed skight and very rapidly and totally reversible irritation only. See robust summaries in 7.3.1 and .3.2,