Formaldehyde, oligomeric reaction products with phenol

Endpoint summary

Description of key information

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

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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.

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

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

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

2.5 and 5% in petrolatum

Adequacy of induction:

not specified

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Various Patch tests were performed to determine the dermal sensitization potential of the test chemical. The results are summarized below:

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.

This is supported by a study which reports of Ten cases of contact dermatitis associated with the usage of the test chemical. The affected subjects include six foundry workers, two aircraft construction workers and one analytical chemist. Irritant contact dermatitis was identified in four persons with hand dermatitis, all with negative patch tests to PFR. Recycling of the hardened sand may be contributory. Two patients (cases 1 and 2) with allergic contact dermatitis were identified. Case 1, with dermatitis of the hands, was allergic to formaldehyde. Case 2, with an exposure pattern rash with generalised secondary spread, was shown to be allergic to his PFR. Allergic Contact Dermatitis from Resinated Laminates Two patients (cases 3 and 4), aircraft construction workers with hand dermatitis, were shown to be allergic to PFR which impregnated resinated laminates handled before they were hardened. Allergic Contact Dermatitis from Chemicals Used in Brake Linings One patient (case 5), an analytical chemist with exposure pattern dermatitis, was allergic to a combination of PFR, cashew nut formaldehyde resin and cashew nut oil. He worked for a company producing brakes and handled these materials in his work.

On the basis of observed positive allergic reaction to the skin it can be concluded that the test chemical was a skin sensitizer.

The above studies are further supported by Patch test conducted on 26 patients to determine the sensitization potential of the test chemical.

26 patients were patch tested with the basic substances phenol, formaldehyde and para tertiary-butyl phenol and the P-F-R 1 and P-F-R-2. 26 Human patients were applied a patch of 5% w/w Formaldehyde, oligomeric reaction products with phenol in petrolatum.

Adverse reactions to the resins include depigmentation (3), irritant dermatitis chemical burns (5) and allergic contact dermatitis of immediate were observed.

Since the positive reaction were observed in human when patch of Formaldehyde, oligomeric reaction products with phenol is applied. It can be concluded that the Formaldehyde, oligomeric reaction products with phenol is skin sensitizer.

The results from the available studies indicate a very strong possibility that the test chemical can be indeed sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The results from the available studies indicate a very strong possibility that the test chemical can be indeed sensitizing to skin.