Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(Reaction product of 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol, 2-(2-hydroxyethylamino)ethanol and formaldehyde), propoxylated
EC Number:
926-000-9
Cas Number:
1180524-77-9
IUPAC Name:
(Reaction product of 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol, 2-(2-hydroxyethylamino)ethanol and formaldehyde), propoxylated

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: polyethylene glycol
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
other: No clinical signs
Gross pathology:
no findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
(1st) 2000 0 / 0/ 3 --- --- 
(2nd) 2000 0 / 0/ 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs after treatment / number of animals treated

Applicant's summary and conclusion

Executive summary:

The LD50 cut-off value is > 5000 mg/kg bw based on the result of a study performed according to OECD TG 423. The test dose of 2000 mg/kg was tolerated without any findings.