Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Basic data given: acceptable study report

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
respiratory irritation
Principles of method if other than guideline:
The experimental procedures consisted of generating and analysing HEA experimental atmosphere in a glass dynamic exposure chamber of 160 liter volume. The chamber was built as such that a subject could protrude his head into the chamber through a rubber diaphragm. Six male volunteers took part in the exposure studies. Each subject would expose himself for three minutes and report his experience to an observer during the exposure.
GLP compliance:
no
Remarks:
(Study was conducted prior to the advent of GLP regulations)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed: 6
- Sex: male
- Profession: Of the six subjects, four were industrial hygiene personnel who were frequently exposed to various chemical plant atmospheres. The remaining two were technical personnel of the Inhalation Toxicology Laboratory who were also frequently exposed to airborne chemical pollutants. One of the subjects had hay fever at the time of experimentation. Otherwise, all subjects could be considered healthy.
Route of exposure:
inhalation
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
HEA experimental atmosphere was generated and analyzed in a glass dynamic exposure chamber of 160 L volume. The chamber was built as such that a subject could protrude his head into the chamber through a rubber diaphragm. Six male volunteers were took part in the exposure studies. Each subject would expose himself for 3 minutes and report his experience to an observer during the exposure.
Examinations:
no data

Results and discussion

Clinical signs:
Irritation of eyes and nose was observed at exposure concentrations of 3 ppm (nominal) and higher.
The severity of irritation increased with concentration and could be tolerated for several minutes at 10 ppm.
Outcome of incidence:
HEA vapour could be detected at concentrations as low as 3 ppm (nominal concentration) and could be tolerated at concentrations as high as 10 ppm. Clinical signs: Irritation of eyes and nose was observed at exposure concentrations of 3 ppm (nominal) and higher. The severity of irritation increased with concentration and could be tolerated for several minutes at 10 ppm.

Any other information on results incl. tables

The results of the human exposure studies are summarized in the table below. It could be seen that HEA could be detected at concentrations as low as 3 -4 ppm, but could be tolerated at concentrations as high as 10 ppm.

Subjects

HEA concentrations [ppm]

nominal 3 ppm (anal. 4.6 ppm)

nominal 6 ppm (anal. 7.1 ppm)

nominal 10 ppm (anal. 10.x* ppm)

 

Eye

Nose

Throat

Eye

Nose

Throat

Eye

Nose

Throat

A

-

+

-

/

/

/

-

+

-

B

-

-

-

-

+

-

-

+

-

C

-

+

-

±

+

-

+

+

-

D

-

+

-

-

+

-

/

/

/

E

-

+

-

/

/

/

/

/

/

F

-

-

-

-

+

-

±

+

-

- no irritation

± practically no irritation

+ definite irritation, but tolerable

/ unwilling to take part in further studies

* original value not readable on TSCAT copy of the report

Applicant's summary and conclusion