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EC number: 700-195-9 | CAS number: 223398-24-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [TN]Gro 266[/TN][SPEC][/SPEC]][AM][/AM]
- IUPAC Name:
- [TN]Gro 266[/TN][SPEC][/SPEC]][AM][/AM]
- Reference substance name:
- 4-acetyl-1-methylpyridin-1-ium 4-methylbenzene-1-sulfonate
- EC Number:
- 700-195-9
- Cas Number:
- 223398-24-1
- Molecular formula:
- C8 H10 N O . C7 H7 O3 S
- IUPAC Name:
- 4-acetyl-1-methylpyridin-1-ium 4-methylbenzene-1-sulfonate
- Details on test material:
- Gro 266
Batch No.: GRO-RN-98810-003
SAT 080010
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The gauze patch was applied to the intact skin of the clipped area.
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g test item moistened with approximately 0.5 ml sterile water
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- other: animal #2 and animal #3
- Time point:
- other: 24 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification on criteria (Commission Directive 2001/59/EC of August 2001), GRO 266 is considered to be "not irritating" torabbit skin.
- Executive summary:
The primary skin irritation potential of GRO 266 was investigated according to OECD test guideline no. 404 . The moistened test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.33 and 0.33, respectively and the mean oedema score was 0.00 for all three animals.
The application of GRO 266 to the skin resulted in mild signs of irritating including slight erythema. This effect was reversible and was no longer evident 48 hours after treatment in all animals. A light yellow staining produced by the test item was noted in one animal 1 hour after treatment.
No corrosive effect were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus the test item did not induce significant or irreversible damage to the skin.
Based upon the reffered classification criteria (Commission Directive 2001/59/EC of August 2001), GRO 266 is considered to be "not irritating" to rabbit skin.
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