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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
only 9 subjects exposed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation was provoked through exposure to n-butanol for 30 min. Epithilium damage, tear film stability and the number of inflammatory cells in tear fluid were measured.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Butan-1-ol
EC Number:
200-751-6
EC Name:
Butan-1-ol
Cas Number:
71-36-3
Molecular formula:
C4H10O
IUPAC Name:
butan-1-ol
Test material form:
liquid

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 9
- Sex: no data
- Age: 18 - 45
- Race: no data
- Demographic information: no data
- Other: None was a seriously addicted user of drugs or alcohol, none had seroous diseases of the heart or the lungs. All had normal vision, no glasses, and no contact lenses. They had no diseases of the eyes or nose, no diagnosed allergies, and no heavy occupational exposure to chemicals or dust.
Route of exposure:
ocular
Reason of exposure:
intentional
Details on exposure:
Human eye irritation was provoked through exposure to n-butanol (eye only). The standard goggle system was used for this method, which consisted of a source-delivering system, an exposure controller, detectors controlling exposure levels, goggles and a rating system. A VOC generator was used to generate a controlled and continuous flow of an atmosphere polluted with n-butanol. The aim was to achieve the 50% of irritation (of maximum on a linear scale) on average during each exposure.
Subjects were divided into three groups and three trials were carried out over a period of 3 weeks. Each trial consisted of:
pre-measurements, half an hour of exposure, immediate post-trialmeasurements, and, 1 h later, the next post-trial measurements.
The following morning the final post-trial measurements were made.
Examinations:
- Other:
Epithilium damage, tear film stability and thenumber of inflammatory cells in tear fluid were measured.

Results and discussion

Clinical signs:
No changes in tear film stability and conjunctival corrosion.

Applicant's summary and conclusion