Registration Dossier
Registration Dossier
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EC number: 700-887-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to the OECD guideline 404 and is fully GLP-compliant. As no study for the reaction mass of L-alanyl-L-glutamine and potassium chloride is available, studies conducted with the two main components L-alanyl-L-glutamine and potassium chloride (such as this) were used for read-across in order to avoid unnecessary repitition of testing. As no synergistic or antogonistic effects from either of the main components is expected, the information derived from both main components separately is considered to be reliable for classification of the reation mass of L-alanyl-L-glutamine and potassium chloride.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- other: White russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG
- Age at study initiation: 9-10 months
- Weight at study initiation: 2.3-2.54 kg
- Housing: individually in stainless steel cages with grating floor
- Diet: standard Diet ssniff K ("special diet for rabbits") approx. 120 g/day / animal
- Water: drinking water ad libitum
- Acclimation period: 1 day under test conditions before application of the product
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24.4
- Humidity (%): 30-50
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 1.6 ml demineralized water
VEHICLE
- Amount(s) applied: 1.6 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days post application
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: applied on the shorn dorsal skin area between shoulder and sacrum (approx. 6.25 cm²)
REMOVAL OF TEST SUBSTANCE
- Washing: yes, after the end of the exposition time remaining test material was gently washed of
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
The evaluation of the cutaneos irritation effect at observation times 1, 24, 48 and 72 hours post application was expressed by an irritation index.
The arithmetical mean values of the individual grades obtained from the skin areas at observation times 1, 24, 48 and 72 hours were calculated - separately for erythema- /eschar and edema formation. The irritation index is represented by the sum of these two mean values.
A corresponding gradation was allocated to this index by the following scheme:
Index Ranges Gradation
0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderatly irritant
5.1 - 8.0 severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not irritating
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