Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
according to Fed. Reg. 38, No. 187, § 1500.42 (Draize test)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-hydroxyethanesulphonate
EC Number:
213-037-4
EC Name:
Sodium 1-hydroxyethanesulphonate
Cas Number:
918-04-7
Molecular formula:
C2H6O4S.Na
IUPAC Name:
sodium 1-hydroxyethane-1-sulfonate
Details on test material:
Name of the test substance used in the study report: Acetaldehydbisulfit spezial = 1-Hydroxy-1-ethyl-natriumsulfonat
pH: 6.8 of a 5% aqueous solution

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Body weight: 2.3 - 2.8 kg
The animals were offered a standardized animals laboratory diet.

Test system

Vehicle:
other: olive oil
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
Instillation of 100 mg
Concentration: 95.3% in olive oil (w/v)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test compound is applied to the inside surface of the lower eyelid of the right eye. The lids are the gently held together for one second.
Readings of the raction of the palpebral conjunctivae and of the eye are mad 1, 24, 48 and 72 hours after instillation.
The test substance was not washed out.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met