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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 22 September and 5 October 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, OECD Guidelines 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:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Young adult animals weighing 3209 to 3587 grams at initiation of dosing were identified by eartag and housed in individual suspended wire mesh cages. The animals were acclimated to laboratory conditions for a minimum of seven days prior to dosing. They were provided PMI Nutrition International, Inc Certified Rabbit LabDiet(R) 5322 feed (approx. 150g/day) during the study and Municipal water ad libitum. Environmental conditions were controlled: 68.2-69.1 deg F, 35.8 to 64.1 % humidity and 12 hours light/12 hour dark cycles.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
13 days
Number of animals:
6
Details on study design:
A group of 6 animals were acclimated for a minimum of 7 days. A dose of 0.5 ml then was applied to a shaved, unabraded site on each animal. A semi-occlusive wrapping was applied to hold the test material in place. At the end of a 4 hours, the wrapping was removed and the site was wiped with a disposable towel moistened with deionized water to remove the test material. The test sites were then evaluated in accordance with the method of Draize at approximately 30-60 minutes, 24, 48 and 72 hours and daily through day 13 if irritation persisted. Animals were observed twice daily for mortality, and body weights were recorded at day 0 and termination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 24 hours
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 48 Hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 72 Hours
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: day 13
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 24 Hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(Initact skin)
Basis:
mean
Time point:
other: 48 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
mean
Time point:
other: 72 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
No mortality or effects on body weight were observed.

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 a skin irritant.
Executive summary:

A study was undertaken in 1999 (Kerr, 1999) to investigate the skin irritation potential of Magnesium sulfonate (CAS 231297 -75 -9) in New Zealand White rabbits. A group of 6 animals were acclimated for a minimum of 7 days. A dose of 0.5 ml then was applied to a shaved, unabraded site on each animal using OECD Guideline 404. A semi-occlusive wrapping was applied to hold the test material in place. At the end of a 4 hours, the wrapping was removed and the site was wiped with a disposable towel moistened with deionized water to remove the test material. The test sites were then evaluated in accordance with the method of Draize at approximately 30-60 minutes, 24, 48 and 72 hours and daily through day 13 if irritation persisted. Animals were observed twice daily for mortality, and body weights were recorded at day 0 and at termination. Mean erythema scores at 24, 48 and 72 hours were 1.83, 1.67, and 1.83, respectively and were fully reversible by day 13. Mean oedema scores at 24, 48 and 72 hours were 0.17, 0, and 0, respectively and were fully reversible by 48 hours. No mortality or effects on body weight were observed. Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.