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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
Study period:
Between 21 May 1992 and 11 June 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols/ standard guideline and to GLP standards, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: U.S. Federal Hazardous Substances Act (16 CFR 1500)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Identification: Magnesium sulfonate
Description: viscous, dark brown liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult animals were acclimated for at least one day before use. The animals were housed individually in suspended wire mesh cages, were supplied Purina Laboratory Chow or a the comparable diet and tap water ad libitum, and were maintained on a 12 hour light and 12 hour dark cycle. A cage card was used to identify each animal.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as the control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
A dose of 0.1 ml of the test material was instilled in one eye of each animal. The other eye served as the control. The eyes of each animal were observed at 24, 48, and 72 hours according to the method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects were noted.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects were noted.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.39
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.45
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008 this substance is not classified as an eye irritant.
Executive summary:

The eye irritation potential of Magnesium sulfonate was evaluated using a modified procedure of the basic criteria established by the U.S. Federal Hazardous Substances Control Act (16 CFR 1500). A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 ml of the test article instilled into one eye. The other eye served as a control. Animals were observed at 24, 48, 72 hours in accordance with the method of Draize. Mean 24, 48, and 72 hour corneal, iris and conjunctival erythema and chemosis scores were 0, 0, 0.39 and 0.45, respectively. Based on these results this substance is not classified as an eye irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.