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PBT assessment

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PBT assessment: overall result

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Name:
boundary composition of tetrachlorophthalic anhydride
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Name:
Tetrachlorophthalic anhydride
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The relevant PBT (persistent, bioaccumulative, toxic) criteria according to the REACH regulation and the corresponding properties of tetrachlorophthalic anhydride are compiled in the following Table:

 

PBT and vPvB criteria and the corresponding properties of tetrachlorophthalic anhydrideand its hydrolysis product tetrachlorophthalic acid

 

Criterion

PBT criteria

vPvB criteria

Tetrachlorophthalic anhydride

Criterion
fulfilled?

P

Half-life in marine water >60 d, or
half-life in fresh- or estuarine water >40 d, or
half-life in marine sediment >180 d, or
half-life in fresh- or estuarine water sediment >120 d, or
half-life in soil >120 d

Half-life in marine, fresh or esturarine water >60 d, or
half-life in marine, fresh or esturarine sediment >180 d, or
half-life in soil >180 d

Tetrachlorophthalic anhydride is not readily biodegradable but it is degraded rapidly by hydrolysis having a half-life < 5 minutes at 25°C at pH 4,7 and 9. The hydrolysis product is hydrolytically stable.

Tetrachlorophthalic anhydride = No

 

Tetrachlorophthalic acid = Yes

B

BCF >2000

BCF >5000

 

Calculated BCFs of 541 and 3 indicate no bioaccumulation potential for both, tetrachlorophthalic anhydride and tetrachlorophthalic acid

No

T

Long-term NOEC for marine or freshwater organisms < 0.01 mg/l

 

No information available

No/yes

T

CMR

Not applicable.

Not classified as CMR

No

T

Other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC

Not applicable

Not classified as T, R48, or Xn, R48 according to Directive 67/548/EEC

No

As a definitive conclusion on the PBT or vPvB properties, based on the criteria set down in Annex XIII of the REACH regulation cannot reached, the whole available information is taken into account, in order to decide whether the substance is to be considered as a potential PBT/vPvB substance.

 

The information relevant for screening for P, B, or T properties is compiled in the following table:

 

Screening criteria for P, vP, B, vB and T

Criterion

Type of data with its criterion

Screening assignment

Tetrachlorophthalic anhydride

Criterion fulfilled?

P

Readily biodegradable in a Ready biodegradability test

Not P and not vP

The substance is not readily biodegradable. The hydrolysis product tetrachlorophthalic acid is considered to be not readily biodegradable.

P / vP

P

Readily biodegradable in a Enhanced ready biodegradability test

 

Not P and not vP

No information available

 

P

≥ 70% mineralisation (DOC removal) within 7d; log phase no longer than 3d; removal before degradation occurs below 15%; no pre-adapted inoculum
in a Zahn-Wellens Test (OECD 302B)

≥ 70% mineralization (O2 uptake) within 14 days; log phase no longer than 3d; no pre-adapted inoculum
in a MITI II test (OECD 302C)

Not P

No information available

 

P

Does not biodegrade fast (probability < 0.5) and ultimate biodegradation timeframe prediction: ≥ months (value < 2.2)
or
Does not biodegrade fast (probability < 0.5) and ultimate biodegradation timeframe prediction: ≥ months (value < 2.2)

in Biowin 2 (non-linear model prediction) and Biowin 3 (ultimate biodegradation time)
or
in Biowin 6 (MITI non-linear model prediction) and Biowin 3 (ultimate biodegradation time)

P

No information available

 

B

e. g. BMF >1
in Convincing evidence that a substance can biomagnify in the food chain (e. g. field data)

B or vB, definitive assignment possible

No information available

 

B

Log Kow ≤ 4.5
in Octanol-water partitioning coefficient (experimentally determined or estimated by valid QSAR)

Not B and not vB

As tetrachlorophthalic ahydride decomposes rapidly in water, the hydrolysis product tetrachlorophthalic acid is taken into account for assessment on bioaccumulative properties. A BCF of 3.16 has been calculated with the EPISuite Estimation Program (BCFWIN) taking the measured log Kow in account, indicating no significant potential for bioaccumulation.

Not B and not vB

T

EC50 or LC 50 < 0.01 mg/L
in Short-term aquatic toxicity (algae, daphnia, fish)

T, criterion considered to be definitely fulfilled

72h-EC50 = 84 mg/l

Not T

T

EC50 or LC50 < 0.1 mg/L
in Short-term aquatic toxicity (algae, daphnia, fish)

T

72 h-EC50 = 84 mg/l

Not T

T

NOEC < 30 mg/kg food
in Avian toxicity (subchronic or chronic toxicity or toxic for reproduction)

T

No information available

 

 

Persistence Assessment

The table demonstrates that tetrachlorophthalic anhydride does not fulfil the P or vP criteria. The hydrolysis product tetrachlorophthalic acid fulfil the P or vP criteria, as the substance is considered to be not readily biodegradable, based on the result of a test on ready biodegradability using tetrachlororphthalic anhydride as test substance.

 

 

Bioaccumulation Assessment

The table demonstrates that neither tetrachlorophthalic anhydride nor its hydrolysis product tetrachlorophthalic acid do not fulfil the B or vB criteria.

 

 

Toxicity Assessment

The substance is not classified as category 1 or 2 Carcinogenic, Mutagenic or toxic to Reproduction (CMR). Regarding the screening criteria for toxicity, the acute toxicity effect concentration (L(E)50) for marine or freshwater organisms is not less than 0.01 mg/l. There are no indications of acute toxicity, and neither the substance nor its hydrolysis product show evidence of long-term toxicity. Tetrachlorophthalic anhydride and the hydrolysis product tetrachlorophthalic acid do not fulfil the criteria for T classification.

 

 

Summary and overall Conclusions on PBT or vPvB Properties

A substance is identified as a PBT substance if it fulfils all three PBT criteria described above. The B and the T criterion are not fulfilled, and therefore tetrachlorophthalic anhydride cannot be classified as PBT. This is in agreement with the statement of the PBT Working Group summarised in the ECB-Summary Fact Sheet (2007).

A substance is identified as a vPvB substance if it fulfils both vPvB criteria described above. The B criterion is not fulfilled and tetrachlorophthalic anhydride cannot be classified as vPvB.