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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
A single accidental exposure may result in a chemical burn, primary sensitization and allergic contact dermatitis.
Author:
Lasse Kanerva, Kyllikki Tarvainen, Anne Pinola, Timo Leino, Håkan Granlund, Tuula Estlander, Ritta Jolanki, Lars Förström
Year:
1994
Bibliographic source:
Contact Dermatitis, Vol. 31, No. 4, pages 229-235, 1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Patch test
Principles of method if other than guideline:
Patch test was performed to study the skin sensitization potential of the test chemical.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Formaldehyde, oligomeric reaction products with phenol
EC Number:
500-005-2
EC Name:
Formaldehyde, oligomeric reaction products with phenol
Cas Number:
9003-35-4
Molecular formula:
(C6H6O.CH2O)x
IUPAC Name:
Formaldehyde, oligomeric reaction products with phenol
Details on test material:
- Name of test material (as cited in study report): Phenol-formaldehyde resin
- Molecular formula: C6H6O.CH2O)x-
- Molecular weight: 34.133 g/mol
- Substance type: organic
- Physical state: solid
- Smiles notation: c1(c(c(ccc1)[CH])O)O[CH]
- InChl: 1S/C8H6O2/c1-6-4-3-5-7(10-2)8(6)9/h1-5,9H

In vivo test system

Test animals

Species:
other: human
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The Skin and Allergy Hospital,University of Helsinki, Finland
-Occupation: Mold worker
- Age at study initiation: 44 year

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5 and 5% in petrolatum
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5 and 5% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
1 human
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period: no data available
- Test groups: test group
- Concentrations: 2.5 and 5% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Test groups: test group
- Concentrations: 2.5 and 5% in petrolatum
- Evaluation (hr after challenge): no data available

OTHER: A mold worker was accidentally exposed to the test chemical when he lifted a barrel assumed to be empty. A liquid containing Urea-formaldehyde resin and free formaldehyde splashed on his face, hands and legs. He quickly washed the exposed areas with copious amount of water and took a shower. After 1 week, he developed eczema on the exposed areas.
Patch testing was performed at University Clinic. Allergic patch test reactions were provoked by the resin used at work and by Phenol-formaldehyde resin [PFR] (P-F-R, Epikon, 1+). After 2 years the patient developed eczema, cough, fever, respiratory distress. Investigations at the Institute revealed occupational asthma and allergic alveolitis. The patient was re-tested with various P-F-Rs.
P-F-Rs from Chemotechnique (2.5 and 5% in petrolatum) and P-F-R novolak from Hermal Chemie(5% petrolatum) produced a 3+ reaction.

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
168
Group:
test chemical
Dose level:
35 % urea phenol formaldehyde resin and 0.5% free formaldehyde
No. with + reactions:
1
Total no. in group:
1
Clinical observations:
Patient develops eczema on the exposed surface after 7 days. 2 year later he developed cough, respiratory distress, fever and eczema
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Sensitizing
Conclusions:
P-F-Rs from Chemotechnique (2.5 and 5% in petrolatum) and P-F-R novolak from Hermal Chemie(5% petrolatum) produced a 3+ reaction.
It was concluded that the patient developed allergic reactions due to various P-F-Rs.
Hence, the test chemical can be considered to be sensitizing to skin.
Executive summary:

Patch test was performed to study the skin sensitization potential of the test chemical.

A mold worker was accidentally exposed  to the test chemical when he lifted a barrel assumed to be empty. A liquid containing Urea-formaldehyde resin and free formaldehyde splashed on his face, hands and legs. He quickly washed the exposed areas with copious amount of water and took a shower. After 1 week, he developed eczema on the exposed areas.

Patch testing was performed at University Clinic. Allergic patch test reactions were provoked by the resin used at work and by Phenol-formaldehyde resin [PFR] (P-F-R, Epikon, 1+). After 2 years the patient developed eczema, cough, fever, respiratory distress. Investigations at the Institute revealed occupational asthma and allergic alveolitis. The patient was re-tested with various P-F-Rs.

P-F-Rs from Chemotechnique (2.5 and 5% in petrolatum) and P-F-R novolak from Hermal Chemie(5% petrolatum) produced a 3+ reaction.

It was concluded that the patient developed allergic reactions due to various P-F-Rs.

Hence, the test chemical can be considered to be sensitizing to skin.