Registration Dossier
Registration Dossier
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EC number: 628-079-2 | CAS number: 3680-69-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 20 Dec 2016 to 05 Jan 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-chloro-7H-pyrrolo[2,3-d]pyrimidine
- EC Number:
- 628-079-2
- Cas Number:
- 3680-69-1
- Molecular formula:
- C6H4ClN3
- IUPAC Name:
- 4-chloro-7H-pyrrolo[2,3-d]pyrimidine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, on 07 Dec 2016.
- Age at study initiation: The male animals were born on 27 Aug 2016.
- Weight at study initiation: The pre-test body weight range was 2.6 -2.8 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g test item per site and moistened with 1.0 ml of distilled water to form a pasty consistency.
- Duration of treatment / exposure:
- 3 minutes, 1 hour, 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 100%
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was gently washed with gauze saturated with distilled water following patch removal.
- Time after start of exposure: 3 minutes, 1 hour, 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 3 minutes, 1 hour, 24 hours, 48 hours, 72 hours
SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- Systemic Observations: No abnormal physical signs were observed.
Body Weights: All three animals gained weight by study termination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to rabbit skin.
- Executive summary:
The skin irritation study is performed using rabbits according to OECD Guideline 404 under GLP.
The test item is not irritating to rabbit skin.
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