Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC, B1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat (Sprague-Dawley)

Administration / exposure

Vehicle:
other: Liquid substance administered neat, as supplied.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 693 mg/kg bw
95% CL:
1 437 - 1 994
Remarks on result:
other: Slope of the mortality curve: 12.13
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 4
Female: 1600 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Mortality:

Two females at 1600 mg/kg and three males and four females
at 2000 mg/kg died during the study. Deaths occurred from
within 4 hours of treatment until day 2.

Clinical signs:

Piloerection was observed in all rats within five minutes of
dosing and throughout day 1. Symptoms continued to be
observed in the majority of surviving animals on day 3 and
in one surviving animal on day 4.

Additional effects observed on day 1 and or later were:-

hunched posture, increased salivation and body tremors, at
all dose levels.

2000 mg/kg group:-

Soft loose faeces and hyperactivity in females, walking on
toes (males only) and chronic convulsions (1 male and 2
females).

2000 and 1600 mg/kg groups:- partially closed eyelids and
prostration.

In the 2000 and 1000 mg/kg groups:- signs of lethargy,
decreased respiratory rate, unsteadiness, protruding eyes
and excitable behaviour, were observed.


Recovery of surviving rats was completed by day 4.


Satisfactory body weight gains were achieved throughout the
study in all surviving animals.
Gross pathology:
Effects on organs:
Macroscopic examination of all decedents at 2000 mg/kg
revealed a darkened appearance of the liver.

No macroscopic abnormalities were observed in either the
decedents at 1600 mg/kg or in surviving animals.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU