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Registration Dossier
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EC number: 210-258-8 | CAS number: 611-19-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.04.1985 - 07.05.1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- α,2-dichlorotoluene
- EC Number:
- 210-258-8
- EC Name:
- α,2-dichlorotoluene
- Cas Number:
- 611-19-8
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- 1-chloro-2-(chloromethyl)benzene
- Details on test material:
- Source: HOECHST AG- Code: GLAC 405- Purity: >99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of test animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eyes were rinsed with physiological saline 24 hours after instillation.
Eyes were inspected for integrity before the testing. A solution of fluorescein, sodium salt (0.01%) was dropped into the eye. Then the cornea was investigated using UV radiation 24 hours before application. Afterwards eyes were rinsed.
24 and 72 hours after application eyes were examined for integrity in the same manner.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Other effects:
- After 24 hours discharge (clear) was noticed in case of all three treated eyes.
Any other information on results incl. tables
All animals gave positive responses. Beside the numerical
grades of ocular reactions displayed in the table beneath
animals excrete a clear liquid at the day of application.
All symptoms were completely reversible within the
observation period.
Numerical grades of ocular reactions after treatment
=====================================================
Animal Region Time after application
No. ------------------------------
1 24 48 72 7 14
hr hr hr hr d d
-----------------------------------------------------
1 Conjunctivae
-Chemosis 2 1 0 0 0 0
-Redness 2 1 1 0 0 0
Iris 1 0 1 0 0 0
Cornea 0 0 2 0 0 0
2 Conjunctivae
-Chemosis 2 2 1 1 1 0
-Redness 2 3 2 2 2 0
Iris 1 1 1 0 0 0
Cornea 0 1 2 0 0 0
3 Conjunctivae
-Chemosis 2 1 0 0 0 0
-Redness 2 2 1 0 0 0
Iris 1 0 1 0 0 0
Cornea 0 0 2 0 0 0
======================================================
These results have led to the conclusion that OCBC had only
slight eye irritant effects which do not meet criteria for
classification and labelling according to EC regulations.
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 o-Chlorobenzylchloride is not subject to specific labelling under current EU regulations.
- Executive summary:
In a primary eye irritation study 0.1 mL of undiluted o-Chlorobenzylchloride (>99 % a.i.) was instilled into the conjunctival sac of the left eye of New Zealand White Rabbits (3 animals) for 24 hours. Eyes were rinsed with physiological saline. The untreated right eye served as control. Animals were observed for 14 days. Observation of the eyes occured 1 h, 24 h, 48 h, 72 h, 7 days and 14 days after application of the test substance. Eye irritation was scored according to OECD GL 405. Conjunctivae showed a diffuse, crimson colour 1 hour after application. On the day of application a moderate circumcorneal hyperaemia of the iris was observed. 24 - 48 hours after application conjunctivae were swelled and showed a colour ranging from diffuse, crimson colour to diffuse beefy red. In one animal signs of opacity were noticed within 24 hours in combination with a swelled conjunctivae showed a diffuse, crimson colour, signs of conjunctivae were seen up to 7 days after application.Development of eye irritation was completely reversible within 14 days. In this study, o-Chlorbenzylchloride exhibited a slight irritating potential.
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