Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 August 1982 - 15 September 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted in accordance with international guidelines.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: yellowish clear liquid
Details on test material:
Label: P0086
Storage: at RT, in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Screening study:
---------------
50, 250, 1250 and 5000 mg/kg

Single dose level study:
---------------------
2000, 2830, 4000 and 5660 mg/kg
No. of animals per sex per dose:
Screening study:
---------------
Four groups, each of 2 fasted rats (1 male, 1 female)

Single dose level study:
---------------------
One group of 10 fasted rats (5 males, 5 females)
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 711 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
2 852 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
2 529 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Screening study:

The mortalities indicated an LD50 in the range 1250 mg/kg - 5000 mg/kg.

Single dose level study:

A total of 26 (12 male, 14 female) of the 40 animals died during the study period. The majority of deaths occurred during the day of dosing. All remaining deaths were noted 24 hours after treatment.

Major signs of toxicity were prostration, lethargy and lacrimation. All surviving animals showed body weight gains at the end of the study period. Major pathological findings were associated with the lungs, which appeared pale in colour with occasional red speckles.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of P0086 in the Wistar-derived rat was estimated to be 2711 mg/kg bodyweight.
Executive summary:

The acute oral toxicity study was performed from August 1982 - September 1982 according to OECD Guideline 401 and GLP.

A total of 26 of the 40 animals died during the study period. Major signs of toxicity were prostration, lethargy and lacrimation. All surviving animals showed body weight gains at the end of the study period. Major pathological findings were associated with the lungs, which appeared pale in colour with occasional red speckles.

The acute oral median lethal dose (LD50) of P0086 in the Wistar-derived rat was estimated to be 2711 mg/kg bodyweight.