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Classification & Labelling & PBT assessment

PBT assessment

Administrative data

Assessed Substance

Assessed substance:
substance itself
Reference
Reference substance name:
Unnamed
IUPAC name:
ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate
CAS number:
440667-78-7
Identity:
L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester
Molecular formula:
C20H25N3O5
Molecular weight:
ca. 387.44
Reference
Name:
L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester
PBT status of the assessed substance:
the substance is not PBT / vPvB

Results of detailed PBT / vPvB assessment

Persistence

Evidence of non-P / non-vP properties
Screening criteria
Criteria based on Annex XIII of REACH
Conclusion
Conclusion on P / vP properties:
not P/vP
Remark:
Due to the degradation (17% in 10 d) the substance is classified as not readily biodegradable. The classification for "not ultimately biodegradable within 28 days” (19% in 28 d) is also not met.

Bioaccumulation

Evidence of non-B / non-vB properties
Screening criteria
Not B and not vB based on: Log Kow ≤ 4.5
Remark:
The log POW of the substance is 0.9
Criteria based on Annex XIII of REACH
Conclusion
Conclusion on B / vB properties:
not B/vB

Toxicity

Evidence of non-T properties
Criteria based on Annex XIII of REACH
Not T based on:
EC10 or NOEC ≥ 0.01 mg/L for marine / freshwater organisms (long-term toxicity):
all Values are above this threshold
and substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008:
this does apply
and no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008:
this does apply
Evidence of T properties
Conclusion
Conclusion on T properties:
not T