Registration Dossier
Registration Dossier
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EC number: 201-151-7 | CAS number: 78-86-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- reliability scoring based on 2002 guideline
- Deviations:
- yes
- Remarks:
- Six rabbits were tested in total and three of the test eyes were washed following administration
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sec-Butylchloride
- IUPAC Name:
- Sec-Butylchloride
- Reference substance name:
- 2-Chlor-butan
- IUPAC Name:
- 2-Chlor-butan
- Reference substance name:
- 2-chlorobutane
- EC Number:
- 201-151-7
- EC Name:
- 2-chlorobutane
- Cas Number:
- 78-86-4
- Molecular formula:
- C4H9Cl
- IUPAC Name:
- 2-chlorobutane
- Test material form:
- other: colourless, clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Sec-butylchloride
- Physical state: liquid
- Lot/batch No.: Not reported
- Storage condition of test material: Stored in refrigerator
- Expiration date: Not specified by sponsor
- Stability under test conditions: not reported
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum, Ssniff Mu Z (pellets), Ssniff Spezialdiaten GmbH
- Water (e.g. ad libitum): ad libitum, drinking water
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2°C
- Humidity (%): 50 to 85%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted
- Ph was 6.5 - Duration of treatment / exposure:
- 0.1 mL of the test material was placed into the conjunctival sac of the left eye while the right eye served as control.
- Observation period (in vivo):
- 1, 24, 48, and 72 hour after treatment
- Number of animals or in vitro replicates:
- 3 animals in total
- Details on study design:
- SCORING SYSTEM:
Cornea opacity- degree of density (area most dense taken for reading): Grade
No ulceration or opacity: 0
Scattered or diffused areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
Iris: Grade
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Conjunctivae Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, cornea, and iris): Grade
Blood vessels normal: 0
Some blood vessel definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red appearance: 3
Chemosis (lids and/or nictating membranes): Grade
No swelling: 0
Any swelling above normal: 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half-closed: 3
Swelling with lids more than half-closed: 4
TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1, 24, 48, 72 hours after treatment using an ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 1 hr
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 71 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 1 hr
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 47 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under conditions of this test to investigate eye irritation/corrosion to rabbits 2-chlorobutane was found not to be classfied as irritant to eyes when applying the criteria for classification as described in CLP (Regulation (EC) No 1272/2008), respectively DSD (Directive 67/548/EEC).
- Executive summary:
The substance showed a marked conjunctivae redness and chemosis directly after exposure to eyes of rabbits (1 hr following exposure), which quickly reversed after 48 hours. Thus, wehn applying the criteria as described in GHS respectively CLP (Regualtion (EC) No 1272/2008) the substance is not to be classified as having irreversible effects to eyes respectively being irritant to eyes.
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