Registration Dossier
Registration Dossier
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EC number: 454-800-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- May 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 454-800-3
- EC Name:
- -
- Cas Number:
- 70258-18-3
- Molecular formula:
- C6H5Cl2N
- IUPAC Name:
- 2-chloro-5-(chloromethyl)pyridine
- 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: Interfauna UK Ltd.
- Age at study initiation: not specified
- Weight at study initiation: 2.8, 3.0 and 3.7 kg (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: contralateral skin part of the flank with vehicle exposure served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin areas were cleaned with water
- Time after start of exposure: ca. 4 hours after start of exposure
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- score 4 after 7 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- score 4 after 7 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- score 4 after 7 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- score 4 after 7 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- score 4 after 7 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- score 4 after 7 days
- Remarks on result:
- probability of severe irritation
- Other effects:
- The skin was indurated after 7 days in animal 3 and necrotic in animal 1.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In a dermal irritation/corrosion test the test substance formulated in water was corrosive to the skin of rabbits according to OECD TG 404. Within the 7-day post-observation period no restitution with normal skin findings at the application site were observed.
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