Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2001

Materials and methods

Type of study / information:
Airborne Concentrations of Ethyl and Methyl Cyanoacrylate in the Workplace
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was conducted at an adhesive production facility in Puerto Rico. The air sampling programm was conducted in an attempt to characterize peak airborne concentrations of ECA for those tasks associated with the highest probability of worker exposure. For more continuos tasks, longer samples were collected.The samples were analysied using the OSHA 55 procedure.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
not specified
Details on study design:
For this study, sample collection was performed using Tenax collection tubes. Each sample was desorbed in a 44:56 (acetonitrile/0.2% phosphoric acid in water) solution immediately after collection and analyzed within 24 -48 hours of sample collection on a HPLC with UV detector.
A total of 172 personal and area samples were collected at the plant. 10 samples were blank that were used for quality control purposes. Of the 162 remaining samples, 152 were analyzed for ethyl cyanoacrylate (93%) and 10 were analyzed for methyl cyanoacrylate (7%). the majority of the samples were collected in the bottling and packaging area (71%) and the mixing area (19%), in which most of the workers are located.
Air sampling pumps were worn on the belts of individuals or mounted in areas of interest. The sorbent tubes were placed in the brathing zone of individuals for personal samples, an in either worst case or representative zones for area samples.
Exposure assessment:
measured
Details on exposure:
Type of exposure measurment:
The air sampling programm was conducted in an attempt to characterize peak (7-20 min, short term) airborne concentrations of ECA for those tasks associated with the highest probability of worker exposure. For more continuos tasks, longer (30-130 min) samples were collected.
some 6 to 8 hour average samples also were collected.

Results and discussion

Results:
The results can be found in the table below.

Any other information on results incl. tables

ECA/MCA Air Sampling Data for the Mixing Operator

 

 

 

Range

 

Sampling Activity/Sampling Period

Sample Type

Number of Samples

Minimum

Maximum

Mean

Task 1: Loading vessels

 

 

 

 

 

Peak (5-15 min)

Personal

3

<0.0057

0.067

0.039

 

Area

3

0.055

0.13

0.084

Interval (25-130 min)

Personal

3

0.05

0.09

0.072

Task 2: Adding solid additives

 

 

 

 

 

Peak (5-15 min)

Personal

3

0.012

0.180

0.071

 

Area

1

-

-

0.074

Task 3: Drum loading

 

 

 

 

 

Peak (5-15 min)

Personal – with LEV

1

-

-

0.067

 

Personal –without LEV

10

0.058

1.5

0.650

 

Area – with LEV

1

-

-

0.100

 

Area – Without LEV

4

0.164

0.9

0.470

 

Area – worst case

4

0.45

2.2

1.360

Interval (25-130 min)

Personal – with LEV

1

-

-

0.028

 

Personal –without LEV

1

-

-

0.140

Task 4: Decanting

 

 

 

 

 

Peak (5-15 min)

Personal

1

-

-

0.16

Task 5: Discarding off-spec product

 

 

 

 

 

Peak (5-15 min)

Personal

2

<0.005

0.11

0.056

All Tasks

 

 

 

 

 

TWA (360-480 min)

Personal

1

-

-

0.069

 

Area

2

0.016

0.02

0.018

Note: All units in ppm. Area worst case = samples collected 2-4 inches above drum and are not representative of worker exposure. – Not applicable

 

 

ECA Air Sampling Data for Bottling and Packaging Operator

 

 

 

Range

 

 

SamplingActivity/Sampling Period

Sample Type

Number of Samples

Minimum

Maximum

Mean

Standard Deviation

Task 1: Bottling, packaging, and labeling

 

 

 

 

 

 

Peak (5-15 min)

Personal

19

0.01

0.087

0.049

0.021

Interval (25-130 min)

Personal

60

<0.001

0.089

0.040

0.016

 

Area

4

0.016

0.063

0.047

0.021

Peak Task 2: Product line change

 

 

 

 

 

 

Peak (5-15 min)

Personal

6

0.023

0.11

0.084

0.033

Interval (25-130 min)

Personal

1

-

-

0.260

-

Task 3: Machine calibration

 

 

 

 

 

 

Peak (5-15 min)

Personal

1

-

-

<0.0039

-

All Tasks

 

 

 

 

 

 

TWA (360-480 min)

Personal

10

0.014

0.048

0.035

0.010

 

Area

7

0.019

0.056

0.034

0.012

Note: All units in ppm. – Not applicable

 

Applicant's summary and conclusion

Conclusions:
The air sampling methods used in the study provide reliable results that are consistent with other sampling programs and are superior to the OSHA sampling methods.
the results of this air sampling program indicate that when handled at room temperature, both methyl 2-cyanoacrylate (MCA) and ethyl-cyanoacrylate (ECA) produce airborne concentrations that are nearly always less than about 0.1 ppm, which is much less than the threshold of irritation.
Executive summary:

A survey waas conducted of persons who manufacture, mix, bottle, and package methyl 2-cyanoacrylate (MCA) and ethyl-cyanoacrylate (ECA). Airborne concentrations of these cyanoacrylates also were measured during waste-handling operations. During a 1 -week period, 162 personal and area samples were colleceted. About 90% of the samples were analyzed for ECA (the predominant adhesive being manufactured at the facility). About 50% of these samples were collected during periods of 15 min or less, the remainder for 15 to 240 min. Some 8 -hour time weighted average (TWA) samples also were collected. Samples were colleceted using Tenax tubes with subsequent analysis by HPLC. Most samples were collected where highest exposure was likeky (e.g. during mixing, bottling, and packaging). Peak concentrations of ECA for the mixing operators ranged from 0.039 ppm to 0.650 ppm, while varoius 10-min to 1 -hour activities were performed, with a TWA concentration of 0.07 ppm. Personal short-term airborne concentrations of ECA for bottling and packaging workers (n = 60) were 0.040 ppm ± 0.016 ppm (mean ± standard dviation), with similar 8 -hour TWA concentrations due to the continuous nature of bottling and packaging. Other personal samples were not significantly different. The area samples were normally within a factor of 2 of the peak personal sampling results. These data indicate that, when handled at room temperature and relative humidity range from 40 -69%, both MCA and ECA produce airborne concentrationss that are nearly always less than about 0.1ppm, which is less than the threshold of irritation.