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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Referenceopen allclose all

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 452 (Chronic Toxicity Studies)
GLP compliance:
not specified
Limit test:
no
Species:
dog
Strain:
Beagle
Sex:
male/female
Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
737 days
Frequency of treatment:
Daily
Remarks:
Doses / Concentrations:
0.01, 0.1 & 1%
Basis:
nominal in diet
No. of animals per sex per dose:
2 dogs/sex/dose
Control animals:
yes
Observations and examinations performed and frequency:
BODY WEIGHT: Yes
- Time schedule for examinations: daily

HAEMATOLOGY: Yes
- Time schedule for collection of blood: on days 224, 395, 591 & 724

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 730

URINALYSIS: Yes
- Time schedule for collection of urine: eight 24-hr collections/dog between day 692 and day 732
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
BODY WEIGHT AND WEIGHT GAIN
0.1 & 1%: growth arrest

HAEMATOLOGY
0.1 & 1%: anemia

CLINICAL CHEMISTRY
1%: decreased resistance of eruthrocytes to hypotonicity

GROSS PATHOLOGY
1%: peripherolobular fatty change in the liver, marked increase in liver weight

HISTOPATHOLOGY: NON-NEOPLASTIC
1%: moderate degree of liver damage
Dose descriptor:
NOAEL
Effect level:
2 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: growth inhibition; gross pathology
Critical effects observed:
not specified
Conclusions:
No evidence of toxicity to dogs was encountered during continued feeding of 0.01% DPA diets for 2 years, corresponding to a total consumption of 1.54 g/kg. The derived NOAEL value is thus 2 mg/kg/day.
Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 452 (Chronic Toxicity Studies)
GLP compliance:
not specified
Limit test:
no
Species:
rat
Strain:
other: Slonaker-Addis
Sex:
male/female
Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
Daily
Remarks:
Doses / Concentrations:
0, 0.001, 0.01, 0.1, 0.5, 1.0%
Basis:
nominal in diet
No. of animals per sex per dose:
20 rats per sex per dose
Control animals:
yes
Observations and examinations performed and frequency:
BODY WEIGHT: Yes
- Time schedule for examinations: once a week during 5 months, once a month thereafter


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes (unit: g/rat/day)
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes


HAEMATOLOGY: Yes
- Time schedule for collection of blood: days 126, 182, 230, 267, 360, 483 (controls); days 126, 177, 231, 267, 360, 463 (test group 1%)
- How many animals: controls group, test group 1%
- Parameters checked in table [No.2] were examined.


URINALYSIS: Yes
- Time schedule for collection of urine: every 16-hour during days 172-175 and 250-253
- Metabolism cages used for collection of urine: Yes
- Parameters checked in table [No.3] were examined.


OTHER: Reproduction performance
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Statistics:
Analysis of Duncan for growth inhibition
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
BODY WEIGHT AND WEIGHT GAIN
0.1% females: depressed average weight
0.5 and 1.0% males and females: growth arrest

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
0.5 & 1.0% males and females: lower average daily consumption


GROSS PATHOLOGY
0.1%: cystic dilatation of renal tubules
0.1-0.5%: occurence of chronic nephritis


OTHER FINDINGS: REPRODUCTION PERFORMANCE
dose-related decrease of the average size of the litters
Dose descriptor:
NOAEL
Effect level:
3 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: growth inhibition; gross pathology
Critical effects observed:
not specified
Conclusions:
There was no evidence of toxicity to rats ingesting an average of 2.25 g/kg DPA (0.01% DPA diet for 2 years). This corresponds to a NOAEL value of 3 mg/kg/day.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
Study duration:
chronic
Species:
dog
Quality of whole database:
K2
Organ:
other: Hematological system, kidneys, spleen, liver

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available information on the substance, the substance meets the classification criteria for STOT Rep. Exp. Category 2  in accordance with Regulation 1272/2008 (CLP)