Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. The GLP status of the study is uncertain. Read-across is considered to be scientifically valid and reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Remarks:
Although a statement regarding GLP was not available with the study report, it is known that this laboratory conducted studies in compliance with GLP at this time.
Test type:
other: LD50
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Hilltop Wistar albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200- 300g

Administration / exposure

Route of administration:
other: intubation
Vehicle:
other: none
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: not reported

Doses:
16.0, 8.0, 4.0, 2.0 and 1.0 ml/kg bw in males; 16.0, 8.0, 4.0 and 2.0 ml/kg bw in females
No. of animals per sex per dose:
45
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Body weights were recorded on days 0, (before dosing), 7 and 14 (prior to termination).

- Necropsy of survivors performed: yes.

- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: At necropsy, each animal was subjected to gross pathologic evaluation.
Statistics:
LD50 with 95% confidence limits; males 7.34 (4.61 to 11.7) ml/kg; females 7.46 (5.16 to 10.8) ml/kg. LD50 slopes; males 3.67, females 4.22.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7.34 - 7.46 mL/kg bw
Remarks on result:
other: Equivalent to 7120 and 7236 mg/kg bw based on relative density of 0.97 g/cm3
Mortality:
Deaths occurred at 2.5 hours to 4 days.
Clinical signs:
Sluggishness, red to brown discharge (around nose, eyes and anus), lacrimation, piloerection, unkempt appearance, prostration, emaciation and unsteady gait were amongst the signs of toxicity observed. Survivors recovered at one to 5 days. With the exception of an enlarged kidney in one female animal in the 8.0 ml/kg bw dose group, there were no remarkable gross lesions in animals that survived to study termination.   
Body weight:
Males dosed 1 ml/kg gained from the mean of 90g to the mean of 125g, at 2 ml/kg from the mean of 84g to 132g, at 4ml/kg from 68g to 111g and at 8ml/kg from 50g to 90g. Females dosed 2 ml/kg gained from the mean of 39g to 61g, 4 ml/kg from 49g to 63g, at 8ml/kg from 26g to 59g.
Gross pathology:
At necropsy, there were several instances of dark red kidney section among victims.

Any other information on results incl. tables

 Table 1: Number of animals dead and time range within which mortality occurred.

 

Dose
(ml/kg)

Mortality (# dead/total)

Time range of deaths (days)

Male

Female

Combined

16

 5/5

 5/5

 10/10

 0 and 1

8

 3/5

 3/5

 6/10

 1,2,3,4

4

 0/5

 0/5

 0/10

 

2

 1/5

 0/5

 1/10

 3

1

 0/5

 0/5

 0/10

 

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 values of 7.34 ml/kg in males and 7.46 ml/kg in females were determined in a reliable study conducted according to a protocol that was comparable to OECD 401. The GLP status of the study is uncertain.