Registration Dossier
Registration Dossier
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EC number: 429-790-9 | CAS number: 137281-39-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 to 6 November 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoic acid
- EC Number:
- 429-790-9
- EC Name:
- 4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoic acid
- Cas Number:
- 137281-39-1
- Molecular formula:
- Hill formula: C15 H14 N4 O3 CAS formula: C15 H14 N4 O3
- IUPAC Name:
- 4-(2-{2-amino-4-oxo-3H,4H,7H-pyrrolo[2,3-d]pyrimidin-5-yl}ethyl)benzoic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Compound 202723
- Storage condition of test material: In the dark at ambient temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Outside vendor
- Weight at study initiation: 2.11-2.18 kg
- Housing: Stainless steel cages (dimensions 77.2 x 70.1 x 48 cm)
- Diet: ad libitum supply of 'Teklad Diet' animal feed
- Water: ad libitum supply of domestic mains quality water
- Acclimation period: At least 7 days prior to commencement of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 19 -20 °C
- Humidity: 54%
- Air changes (per hr): 15
- Photoperiod: 12hr light/dark cycle (light hours 07:00-19:00)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- 500 mg of test material was applied topically to each animal
- Duration of treatment / exposure:
- Contact period of 4 hours
- Observation period:
- Test sites were examined 1,24,48 and 72 hours after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap: Water moistened gauze patches covered with semi -occlusive tape and elastic bandage which was wrapped around the torso of the animal
REMOVAL OF TEST SUBSTANCE
- Washing: Skin was wiped with sterile water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
see Table GRADING OF SKIN REACTIONS from OECD Guideline 404
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:
- 0
- Reversibility:
- other: No reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no reaction
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not classified as skin irritant.
- Executive summary:
The acute dermal irritation potential of a test material, Compound 202723,was investigated in 3 New
Zealand White rabbits.
Animals tested were subjected to a 4 hour exposure of 500mg of the test material applied as supplied, on to the wetted dorsal trunk under a water moistened semi-occusive patch. The test sites were then examined for evidence of irritation 1, 24, 48 and 72 hours after patch removal.
No oedema or erythema was noted in any animal throughout the observation period.
Under the conditions of the study, compound 202723 is considered to be non-irritating to rabbit skin.
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