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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
In principle, the methods described in OECD Guideline 401 were used.
Young adult laboratory rats were purchased from a breeder. 5 rats per sex were treated simultaneously by gavage without a vehicle.
Documentation of clinical signs was performed over a 14 day period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
The clinical signs and findings were reported.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
purity >99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
10000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
no animal died within the observation period

Any other information on results incl. tables

Mortality after

5 males

5 females

1 h

0

0

1 d

0

0

2 d

0

0

7 d

0

0

14 d

0

0

Symptoms in all animals at 10000 mg/kg:

DYSPNEA, APATHY, SPASTIC MOTION, SCRUBBY FUR, ALOPECIA, BAD GENERAL CONDITION

Applicant's summary and conclusion

Executive summary:

No death and no abnormalities observed upon terminal necropsy at a dose level of 10,000 mg/kg Palatinol CE 5250 (CAS 28553-12-0, DINP2) administered undiluted by gavage to ten Sprague- Dawley rats (5 males and 5 females). The observation period was 14 days. Dyspnea, apathy, spastic gait, piloerection, alopecia and poor general state were observed.