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Registration Dossier
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EC number: 202-503-2 | CAS number: 96-37-7
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:
- data from handbook or collection of data
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Tests in inhalation chambers
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- hexane (isomer composition and purity were not specified)
- Species:
- human
- Vehicle:
- other: air (tested in inhalation chambers)
- Duration of treatment / exposure:
- 3-5 min
- Number of animals or in vitro replicates:
- 10 volunteers
- Irritation parameter:
- other:
- Basis:
- mean
- Time point:
- other: after 3-5 min. in inhalation chamber
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Hexane is not irritant to the eye, when humans are exposed up to 500 ppm in the air for a few minutes.
Direct contact with n-hexane vapor (3000 ppm for 24 wk with 5 d/wk for 8 hr/d) with the eyes of rabbits resulted in lacrimation and hyperemia of the conjunctivae. - Executive summary:
Hexane is not irritant to the eye, when humans are exposed up to 500 ppm in the air for a few minutes.
Direct contact with n-hexane vapor (3000 ppm for 24 wk with 5 d/wk for 8 hr/d) with the eyes of rabbits resulted in lacrimation and hyperemia of the conjunctivae.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Tests in inhalation chambers
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-hexane
- EC Number:
- 203-777-6
- EC Name:
- N-hexane
- Cas Number:
- 110-54-3
- Molecular formula:
- C6H14
- IUPAC Name:
- hexane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- hexane (isomer composition and purity were not specified)
Test animals / tissue source
- Species:
- human
Test system
- Vehicle:
- other: air (tested in inhalation chambers)
- Duration of treatment / exposure:
- 3-5 min
- Number of animals or in vitro replicates:
- 10 volunteers
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other:
- Basis:
- mean
- Time point:
- other: after 3-5 min. in inhalation chamber
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- 3-5 min exposure in human volunteers
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Hexane is not irritant to the eye, when humans are exposed up to 500 ppm in the air for a few minutes.
Direct contact with n-hexane vapor (3000 ppm for 24 wk with 5 d/wk for 8 hr/d) with the eyes of rabbits resulted in lacrimation and hyperemia of the conjunctivae. - Executive summary:
Hexane is not irritant to the eye, when humans are exposed up to 500 ppm in the air for a few minutes.
Direct contact with n-hexane vapor (3000 ppm for 24 wk with 5 d/wk for 8 hr/d) with the eyes of rabbits resulted in lacrimation and hyperemia of the conjunctivae.
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