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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Didodecyl nonylphenyl phosphite
EC Number:
252-457-2
EC Name:
Didodecyl nonylphenyl phosphite
Cas Number:
35239-35-1
Molecular formula:
C39-H73-O3-P
IUPAC Name:
Phosphorous acid, didodecyl nonylphenyl ester
Constituent 2
Chemical structure
Reference substance name:
Dodecyl bis(4-nonylphenyl) phosphite
EC Number:
284-117-4
EC Name:
Dodecyl bis(4-nonylphenyl) phosphite
Cas Number:
84787-76-8
Molecular formula:
C42-H71-O3-P
IUPAC Name:
Phosphorous acid, dodecyl bis(4-nonylphenyl) ester
Constituent 3
Chemical structure
Reference substance name:
4-nonylphenyl ditridecyl phosphite
EC Number:
284-119-5
EC Name:
4-nonylphenyl ditridecyl phosphite
Cas Number:
84787-77-9
Molecular formula:
C41-H77-O3-P
IUPAC Name:
Phosphorous acid, 4-nonylphenyl ditridecyl ester
Constituent 4
Chemical structure
Reference substance name:
Bis(4-nonylphenyl) tridecyl phosphite
EC Number:
284-120-0
EC Name:
Bis(4-nonylphenyl) tridecyl phosphite
Cas Number:
84787-78-0
Molecular formula:
C43-H73-O3-P
IUPAC Name:
Phosphorous acid, bis(4-nonylphenyl) tridecyl ester
impurity 1
Reference substance name:
Tris(nonylphenyl) phosphite
EC Number:
247-759-6
EC Name:
Tris(nonylphenyl) phosphite
Cas Number:
26523-78-4
IUPAC Name:
tris(2-nonylphenyl) phosphite
impurity 2
Reference substance name:
Didodecyl phosphonate
EC Number:
244-325-8
EC Name:
Didodecyl phosphonate
Cas Number:
21302-09-0
Molecular formula:
C24H51O3P
IUPAC Name:
Di(n-dodecyl)hydrogen phosphate
impurity 3
Chemical structure
Reference substance name:
Phenol, 4-nonyl-, branched
EC Number:
284-325-5
EC Name:
Phenol, 4-nonyl-, branched
Cas Number:
84852-15-3
Molecular formula:
C15H24O
IUPAC Name:
4-Nonylphenol, branched
Test material form:
liquid
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 678

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
2000 mg/kg
No. of animals per sex per dose:
three males and three females
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 10 days
- Observation for signs and symptoms: yes
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study
Clinical signs:
other: Ruffled für, dyspnea, and hunched posture were seen. Animals recovered within 10 days.
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP Criteria
Conclusions:
In an exploratory study, the acute oral LD50 of TK 12437 in rats was > 2,000 mg/kg. No mortality occurred during the study.