Registration Dossier
Registration Dossier
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EC number: 203-242-7 | CAS number: 104-83-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- α,4-dichlorotoluene
- EC Number:
- 203-242-7
- EC Name:
- α,4-dichlorotoluene
- Cas Number:
- 104-83-6
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- 1-chloro-4-(chloromethyl)benzene
- Details on test material:
- p-Chlorobenzyl chloride, pure.
State of matter: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Rabbits, strain: New Zealand White
- Source: Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: 3 kg
- 2 males, 1 female
ENVIRONMENTAL CONDITIONS
- Diet: mümmel Z 222 (Hoeing Kraftfutterwerk Niedersachsen, Verden/Aller)
- Water: tap water (ad libitum)
- Temperature (°C): 19 - 21 °C
- Humidity: 40 - 50 %
- Photoperiod (hrs dark / hrs light): 12 / 12
- Housing: 1 animal per cage
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of test animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were inspected for integrity before the testing.
The test substance was placed in the conjunctival sac of one eye of each animal.
The lids are then gently held together for about one second. The other eye, which remains untreated, serves as a control.
Eyes were rinsed with physiological saline 24 hours after instillation.
Eyes were examined 1, 24, 48, 72 and 168 hours after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 110
- Remarks on result:
- other: Classification: slightly irritating
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Reversibility:
- fully reversible within: 48 hg
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 h
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Due to the result p-Chlorobenzylchloride is not subject to specific labelling under current EU regulations.
- Executive summary:
In an eye irritation study 0.1 g of undiluted p-chlorobenzyl chloride was instilled into the conjunctival sac of one eye of New Zealand White Rabbits (3 animals) for 24 hours. After 24 h eyes were rinsed with physiological saline.
The untreated eye served as control.
Animals were observed for 7 days.
Observation of the eyes occurred 1 h, 24 h, 48 h, 72 h and 7 days after application of the test substance.
Eye irritation was scored according to OECD GL 405.
The calculated overall irritation score is 4.
In this study, p-chlorobenzyl chloride exhibited a slight irritating potential.
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