Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
1999

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

Constituent 1
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
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.

Categories Display