Registration Dossier
Registration Dossier
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EC number: 929-889-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of Benzeneethanol, 2-chloro-.alpha.-(1-chlorocyclopropyl)-.alpha.-(chloromethyl)- and Oxirane, 2-(1-chlorcyclopropyl)-2-[(2-chlorphenyl)methyl]-
- EC Number:
- 929-889-1
- Cas Number:
- not available
- IUPAC Name:
- Reaction mass of Benzeneethanol, 2-chloro-.alpha.-(1-chlorocyclopropyl)-.alpha.-(chloromethyl)- and Oxirane, 2-(1-chlorcyclopropyl)-2-[(2-chlorphenyl)methyl]-
1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 5.5 months
- Weight at study initiation: 2.0 -2.2 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5 ml neat test item
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Scores were taken 60 minutes, 24, 48, 72 hours and 4 to 9 days after patch removal. Based on most recent guidelines the skin reactions are monitored until the changes observed have completely subsided, however for not more than 14 days after application. Animals that do not reveal any lesions anymore for 24 hours following the first 72 hours of observation are sacrificed.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 6 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: see remarks on result
- Basis:
- animal #1
- Time point:
- other: beginning 4 days and lasting until 8 days after patch removal
- Remarks on result:
- other: delayed reactions: induration, laceration, peeling of the skin
- Irritation parameter:
- other: see remarks on result
- Basis:
- animal #2
- Time point:
- other: beginning 5 days and lasting until 8 days after patch removal
- Remarks on result:
- other: delayed reactions: induration, laceration, peeling of the skin
- Irritation parameter:
- other: see remarks on result
- Basis:
- animal #3
- Time point:
- other: until 9 days after patch removal
- Remarks on result:
- other: no delayed reactions observed
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The test item is slightly irritating to the skin of rabbits according to OECD TG 404 study. All signs were fully reversible within 9 days. No systemic intolerance reactions were observed.
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