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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: case report
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Occupational contact allergy to the epoxy resin hardener 2-methylpentane-1,5-diamine
Author:
Susanne Darr-Foit, Johannes Geier, Peter Elsner, Sibylle Schliemann
Year:
2016
Bibliographic source:
Contact Dermatitis, 74, 115-116

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Guideline of the German Contact Dermatitis Research Group (Schnuch et al., 2008)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylpentane-1,5-diamine
EC Number:
239-556-6
EC Name:
2-methylpentane-1,5-diamine
Cas Number:
15520-10-2
Molecular formula:
C6H16N2
IUPAC Name:
2-methylpentane-1,5-diamine
Test material form:
liquid

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 1
- Sex: male
- Age: 63 y
- Race: white
- Demographic information: none
Clinical history:
- History of allergy or casuistics for study subject or populations: not specified
- Symptoms, onset and progress of the disease: 4-years of work-related contact dermatitis comprising itching, burning, oozing of face, forearms, dorsal surfaces of hands when handling epoxy resin sytems
- Exposure history: work-related, no time span specified
- Aggravating factors both in home and workplace: not specified
- Family history: not specified
- Any other allergic or airway disorders: not specified
- Smoking history: not specified
Controls:
concurrent on exposed subject
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: small Finn Chambers on Scanpor tape (SmartPractice Europe, Reinbeck, Germany)
- Vehicle / solvent: petrolatum
- Concentrations: 0.25% MPMD
- Volume applied: not specified
- Testing/scoring schedule: not specified
- Removal of test substance: after 2 days


EXAMINATIONS
- Grading/Scoring system: not specified, (given as -,?,+,++,+++)
- Statistical analysis: no

Results and discussion

Results of examinations:
SYMPTOMS:
- Frequency, level, duration of symptoms observed: not specified

RESULT OF CASE REPORT:
see Table 1

DISCUSSION:
The authors state that it is probable that the patient was co-sensitized by co-exposure to MPMD and m-xylene diamine, as he handled an epoxy resin system containing both substances.

Any other information on results incl. tables

Table 1 (taken from Darr-Foit et al., 2016)


















Substance and test concentration



reading on day 2 (D2)



D3



D6



2-Methylpentane-1,5-diamine


0.25%


 



?



++



+++


Applicant's summary and conclusion

Executive summary:

A positive patch test reaction to MPMD of a 63-year old male worker with a 4-year history of work-related contact dermatitis due to handling of epoxy resin systems  was observed. The authors state that it was probable that the patient was co-sensitized by co-exposure to MPMD and m-xylene diamine, as he handled an epoxy resin system containing both substances.