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Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: experience in production
Adequacy of study:
key study
Study period:
before 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1999

Materials and methods

Type of study / information:
Internal report of EHS department from former MeadwestVaco (now Ingevity) about skin irritation reports in production.
Endpoint addressed:
skin irritation / corrosion
eye irritation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Individual reports from workers in production, working in the production facility where fatty acids, tall oil, reaction products with maleic acid and triethylenetetramine are manufactured. Following independent reports from workers in a weight of evidence approach applying the precautionary principle, the substance was considered as an irritant to skin, eyes and respiratory tract and appropriate measures were taken to protect workers from exposure. As a result, reportings on irritations reduced significantly.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine, polyamido-amine
Molecular formula:
UVCB
IUPAC Name:
Fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine, polyamido-amine
Constituent 2
Chemical structure
Reference substance name:
Fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine, imido - amidoamine
Molecular formula:
UVCB
IUPAC Name:
Fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine, imido - amidoamine
Constituent 3
Chemical structure
Reference substance name:
Fatty acids, tall oil, reaction products triethylenetetramine.
Molecular formula:
UVCB
IUPAC Name:
Fatty acids, tall oil, reaction products triethylenetetramine.
Test material form:
liquid: viscous
Remarks:
Dark viscous liquid
Specific details on test material used for the study:
Measures were adopted following incident reports by workers for the reaction product "fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine" but it remained unclear whether the finding were associated with the substance as such or eventually also with starting materials such as maleic anhydride and triethylenetetramine, both knowingly being skin and eye corrosives.

Method

Ethical approval:
not applicable
Details on study design:
Reports from workers working in production facility, handling the substance, collected by EHS department and analysed for improvement of handling procedures and risk management measures to be adopted.
Exposure assessment:
not specified
Details on exposure:
The reaction to produce the substance takes place at elevated temperatures where the starting materials and resulting reaction mass are molten. Although the reaction as such takes place in closed vessels, the material is drummed of after the reaction as hot melt, solidifying in transport containers, which results in possibility for exposure of workers to the substance and its vapours.

Results and discussion

Results:
A number of workers informed site management about skin irritations and in a very few cases also a diffuse eye irritation and irritation of the throat, when manufacturing the material. As workers do not only handle the substance "fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine", but also the starting materials maleic anhydride and triethylenetetramine, both knowingly skin and eye corrosives, a clear assignment for irritating effects for a particular substance could not be made. As effects were also observed when drumming of the material following the reaction, where maleic anhydride and triethylenetetramine have mostly reacted, a precautionary approach was taken to classify the final product "fatty acids, tall oil, reaction products with maleic anhydride and triethylenetetramine" as skin, eye and respiratory irritant, provide workers with personal protective equipment and install improvements of the local exhaust ventilation in the area where the material is drummed of as hot melt. These measures were seconded by specific activity training of workers on use of PSE and ways of handling the substance. Following the implementation of risk management measures, incidence reports reduced significantly. Therefore, in a precautionary approach, the substance since then is classified as skin and eye irritant, category 2, as well as respiratory irritant (STOT SE category 3, H335).

Any other information on results incl. tables

All personal records of worker are considered confidential and names of workers and details allowing to track back individuals are not disclosed (only known to site EHS department and medical officer in confidence).

Applicant's summary and conclusion

Conclusions:
Based on incidence reports from workers in production facilities, in a precautionary approach, the substance is classified as skin and eye irritant, category 2 (H315 and H319) and as respiratory irritant (STOT SE 3, H335).