Registration Dossier
Registration Dossier
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EC number: 202-700-3 | CAS number: 98-79-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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:
- other: Method according to the official journal of French Republic (Offical Journal of 21 february 1982)
- Deviations:
- yes
- Remarks:
- powder not moistened; but as skin was scarified we may expect that it was self-moistened. No reading at 48h, but readings at 24+72h consistent. Study stopped at 72h, but reactions were slight and started to reverse.
- Principles of method if other than guideline:
- This method is used to evaluate the index of Primary Irritation induced by a test article, after a single application
Any substance provoking after a single applciation an orthoergic inflammatory cutaneous reaction appearing within 24 hours on the application site is designated as a Primary irritant. - GLP compliance:
- no
Test material
- Reference substance name:
- Pidolic acid
- EC Number:
- 202-700-3
- EC Name:
- Pidolic acid
- Cas Number:
- 98-79-3
- Molecular formula:
- C5H7NO3
- IUPAC Name:
- 5-oxo-L-proline
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: "Elevage scientifiques des dombes, C.E.G.A.V"
- Age at study initiation: Not specified
- Weight at study initiation: 2.3 to 3 kg
- Housing: 1 animal by cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least 1 week before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): 3 000 m3/hr
- Photoperiod (hrs dark / hrs light): 12 hours
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: one flank shaved and abraded and the other flank only shaved
- Vehicle:
- water
- Remarks:
- distilled
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of product (corresponds to > 0.5 g as solid) - Duration of treatment / exposure:
- 24 hours
- Observation period:
- at 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 3x3 cm square patchs
- Type of wrap if used: Adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS: at 24 hours and 72 hours
SCORING SYSTEM:
- Method of calculation: primary dermal irritation index
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks:
- Results tended to show a shift towards reversibility between time point 24 hours and 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks:
- Results tended to show a shift towards reversibility between time point 24 hours and 72 hours
- Irritant / corrosive response data:
- The maximum score at each reading time for all animals and areas (normal and scarified), is 1 for erythema and 0 for edema.
Effects generally show a tendecy to recovery (score 0) at 72h: 5/6 non-scarified areas and 2/6 scarified areas.
No desquamation and skin flexibility alteration.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test item is not classified according to CLP regulation and GHS
- Executive summary:
According to non-GLP study following a national protocol, slight irritation is observed with a tendency to reversibility at 72h.
GHS and CLP classification is not warranted.
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