Registration Dossier
Registration Dossier
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EC number: 470-270-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 470-270-6
- EC Name:
- -
- Cas Number:
- 477773-67-4
- Molecular formula:
- C13H22N2O6K
- IUPAC Name:
- Glycine, N, N' - (1,9-nonandeiyl) bis-, monopotasium salt
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Conditions
Standard Laboratory Conditions.
Air- conditioned with ranges for room temperature 17-23°C, relative humidity 30-70% and apporximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occured, usually following room cleaning. These transient variations are considered not to have any influence on the study. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
Accomodation
Individually in stainless steel caged equipeed with feed hoppers and drinking water bowls.
Diet
Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
Water
Community tap water from Fullinsdorf ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24,48 and 72 hours after exposure
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal number 61
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 0.33
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal number 62
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 0.33
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal number 63
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal number 61
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal number 62
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal number 63
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
VIABILITY /MORTALITY/CLINICAL SIGNS:
No clinicals signs of systemi toxicity were observed in the animals during the study and no mortality occured.
IRRITATION
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.
No abnormal findings were observed on the treated skin of any animal 48 hours after treatment.
A very slight to well-defined erythema was noted in all animals at the 1-hour reading. The erythema persisted as slight in two animals untile the 24-hour reading- At the 1-hour reading all the animals showed a very slight edema which did no persist. No staining produced by the test item of the treated skin was observed.
CORROSION
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be "not irritating" to skin
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