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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Formaldehyde, oligomeric reaction products with phenol
Type of composition:
boundary composition of the substance
Reference substance:
Formaldehyde, oligomeric reaction products with phenol
Reference substance:
Formaldehyde, oligomeric reaction products with phenol
Reference substance:
Formaldehyde, oligomeric reaction products with phenol
Reference substance:
Formaldehyde, oligomeric reaction products with phenol
Reference substance:
Formaldehyde, oligomeric reaction products with phenol
PBT status:
the substance is not PBT / vPvB
Justification:

Classification ofFormaldehyde, oligomeric reaction products with phenolfor effects in the environment:

 

The chemical Formaldehyde, oligomeric reaction products with phenol (CAS no. 9003-35-4) is used as an adhesive and bonding agent for plywood, particle board, fibreboard, insulation, cores for laminates, rubber, wood and construction industry etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Formaldehyde, oligomeric reaction products with phenol. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

Persistence assessment

The tested substance does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

An experiment was performed to determine biodegradability of test chemical phenol formaldehyde resin (CAS no. 9003-35-4) by using guideline ISO DIS 9408 (Ultimate Aerobic Biodegradability - Method by Determining the Oxygen Demand in a Closed Respirometer). The percent degradation of test chemical phenol formaldehyde resin (CAS no. 9003-35-4) was determined by using industrial waste water samples of test chemical and parameter used was Biological oxygen demand. Morethan 60 % degradation was observed in 10 days of indiluted samples and 80% degradation observed in 10 days of diluted samples. On the basis of this percent degradability value it is concluded that test chemical is readily biodegradable in nature.

 

In an another study, the test chemical Formaldehyde, oligomeric reaction products with phenol (CAS no. 9003-35-4) was tested for biodegradability test by using two different inoculums of mixed microbial system. The test chemical was synthesized by using14C-ring-labelled phenol and formaldehyde and parameter used to check biodegradation was labelled CO2evolution. Radioactivity was measured by 100C liquid scintillation counter. The test chemical was put in 125 mL flask at concentration 0.045µCi with two different inoculums in separate flasks for 11 weeks and 5 weeks respectively at pH 7. Sterile control was used for correction for quench. By both the inoculums percent biodegradability was in the range of 0-0.15 %.

 

Based on the result of study which was performed according to standard ISO test guideline, test chemical Formaldehyde, oligomeric reaction products with phenolwas considered to be readily biodegradable in natureand thus likely to be not persistent (not P) in nature.

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The octanol water partition coefficient of the test chemical was determined to be 3.564± 0.002 at 25°C as per OECD TG 117, which is less than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

All of the available short-term eco-toxicity results for fish, invertebrates and algae for the substance indicates the LC50/EC50 value to be >100 mg/l. These value suggest that the substance is not likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be ‘not classified’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations forFormaldehyde, oligomeric reaction products with phenol. By speculation, long-term NOEC for aquatic organisms were not expected for the substanceFormaldehyde, oligomeric reaction products with phenolat concentration below 0.01 mg/L based on the data mentioned above

 

The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.