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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
-
EC Number:
432-130-2
EC Name:
-
Cas Number:
119345-01-6
Molecular formula:
Not applicable ( a generic molecular formula cannot be provided for this UVCB substance)
IUPAC Name:
Reaction products of phosphorous trichloride, with 1,1′-biphenyl and 2,4-bis(1,1-dimethylethyl)phenol
Details on test material:
no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
4%
Details on oral exposure:
no data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 50, 200, 1000 mg/kg bw/day
Basis:
no data
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Control animals:
yes, concurrent no treatment
Details on study design:
no data
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
MORTALITY: No mortality during the test.
CLINICAL SIGNS: No clinical signs were observed during the test.
BODY WEIGHT: No change in all treatment groups.
CONSUMPTION OF FOOD: No change in all treatment groups.
FUNCTIONAL OBSERVATION BATTERY: No established evidence of any abnormal behaviour or anomalies in any animal from any group whatsoever.
GRASPING FORCE: No differences between treatment groups, with no effects noted.
LOCOMOTIVE ACTIVITY : There where no change related effects in any animals.
HAEMOTOLOGY: No differences in all treatment groups.
WEIGHT OF ORGANS: No differences in all treatment groups..
MACROSCOPIC and MICROSCOPIC OBSERVATION: No macroscopic or microscopic abnormalites noted in all animals tested.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Recovery groups at 0 mg/kg and 1000 mg/kg where also assessed. No differences where noted.

Applicant's summary and conclusion

Conclusions:
NOAEL 1000 mg/kg bw/day
NOEL 1000 mg/kg bw/day

No significant effects noted.
Executive summary:

Information from migrated NONS file, as per inquiry number 06-0000020725-70-0000, permission to refer granted by ECHA.

 

Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA. 

 

NOAEL 1000 mg/kg bw/day

NOEL 1000 mg/kg bw/day

 

No significant effects were noted. The substance is not classified.