Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: IRGL Testing Standards 1981
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

   
   

Applicant's summary and conclusion

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.