Registration Dossier
Registration Dossier
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EC number: 200-666-4 | CAS number: 67-72-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: test performed prior to guideline availability but with procedures similar to standard methods and with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- other: Published toxicological report
- Title:
- Unnamed
- Year:
- 2 011
- Reference Type:
- other: Published toxicological report
- Title:
- Toxicological Profile for Hexachloroethane
- Author:
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Year:
- 1 997
- Bibliographic source:
- Not reported
- Reference Type:
- publication
- Title:
- The toxicity of hexachloroethane in laboratory animals.
- Author:
- Weeks MH, Angerhofer RA, Bishop R, Thomasino J, Pope CR.
- Year:
- 1 979
- Bibliographic source:
- Am Ind Hyg Assoc J. 1979 Mar;40(3):187-99. doi: 10.1080/15298667991429499. PMID: 495459.
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: determine the eye irritation potential of the test material by dosing rabbits with a single ocular application, and monitoring ocular reactions.
- Short description of test conditions: the test material was applied in one eye of each rabbit for 24 h as dry technical grade compound. Six rabbits were exposed. Eye reactions were monitored over an observation period of up to 7 days post-exposure.
- Parameters analysed / observed: conjunctivitis, iritis and cornea damage - GLP compliance:
- not specified
Test material
- Reference substance name:
- Hexachloroethane
- EC Number:
- 200-666-4
- EC Name:
- Hexachloroethane
- Cas Number:
- 67-72-1
- Molecular formula:
- C2Cl6
- IUPAC Name:
- hexachloroethane
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Hummel Chemical Company, specifications MIL-H-235B, national stock number 6810-00-N00-001
- Purity: technical grade, 99.8%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- ENVIRONMENTAL CONDITIONS
- Temperature: 24 ± 2°C
- Humidity: 45-55%
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g dry technical grade compound
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24 h, 48 h, 72 h and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done), time after start of exposure: not specified
SCORING SYSTEM: not specified
TOOL USED TO ASSESS SCORE: not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 6
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 6
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.66
- Max. score:
- 6
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: cornea score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- other: cornea score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: cornea score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: cornea score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: cornea score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- other: cornea score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
|
| Scores | Mean scores | |||||
| Time of reading | Rabbit No | ||||||
Structure | Hrs/days | 1 | 2 | 3 | 4 | 5 | 6 | |
Cornea | 24 h 48 h 72 h 7 days | 2 1 0 0 | 0 1 0 0 | 2 1 1 0 | 2 0 0 0 | 2 0 0 0 | 1 1 0 0 | 1.5 0.8 0.2 0.0 |
Iris | 24 h 48 h 72 h 7 days | 1 0 0 0 | 0 0 0 0 | 1 0 0 0 | 1 0 0 0 | 1 0 0 0 | 1 0 0 0 | 0.8 0.0 0.0 0.0 |
Conjunctivae | 24 h 48 h 72 h 7 days | 7 4 1 0 | 4 4 1 0 | 4 4 2 0 | 6 4 1 0 | 6 3 1 0 | 6 3 1 0 | 5.5 4.0 1.0 0.0 |
Cornea Iris Conjunctivae | Mean (24/4/72 h) | 1 0.33 4 | 0.33 0 3 | 1.33 0.33 3.33 | 0.66 0.33 3.66 | 0.66 0.33 3.33 | 0.66 0.33 3.33 |
|
Mild injury to the cornea and some injury to conjunctivae with corneal opacity reversible within 7 days = Toxicity category II
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions applied, the test material produced reversible eye irritation.
- Executive summary:
The eye irritation potential of hexachloroethane was assessed by performing an eye irritation study in New-Zealand White rabbits. There was no information regarding a standardised method or GLP.
The test material (0.1 g) was applied in one eye of each rabbit for 24 h as dry technical grade compound. Six rabbits were exposed. Conjunctivitis, iritis and cornea damage were monitored over an observation period of up to 7 days post-exposure.
The test material caused moderate corneal opacity, iritis and severe swelling and discharge (conjunctivitis) in 5 of 6 rabbits at 24, 48 and 72 h post-exposure. No signs were seen 7 days after administration.
Under the test conditions applied, the test material produced reversible eye irritation and is therefore classified as Eye Irritant Cat. 2 according to the classification criteria of regulation (EC) 1272/2008 (CLP).
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