Registration Dossier

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:
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.