Registration Dossier

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:
guideline study with acceptable restrictions
Remarks:
Study predates GLP but is sufficiently documented, meets generally accepted scientific principles and is acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No follow up study in females; limited details of clinical examinations and pathology,
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no details
- Age at study initiation: 3-4 wk
- Weight at study initiation: 90-120 g
- Fasting period before study: no details
- Housing: no details
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: no details

ENVIRONMENTAL CONDITIONS
no details

IN-LIFE DATES: no details

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw (neat test substance)
Doses:
1.25, 2.5, 5.0 ml/kg bw
No. of animals per sex per dose:
5 males/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighed at days 0 and 14; no details on frequency of observations
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Moving average method.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2.97 mL/kg bw
95% CL:
>= 1.67 - <= 5.28
Remarks on result:
other: approximately 3030 mg/kg bw.
Mortality:
See table 1.
Clinical signs:
See table 1.
Body weight:
See table 1.
Gross pathology:
Among the survivors at 2.5 ml/kg bw, the rat with weight loss (see table 1) had pus in the lungs. No other remarkable findings in survivors. Those that died had purple colouration in the glandular stomach.

Any other information on results incl. tables

Table 1: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

Dose
(ml/kg bw)

Mortality (dead/total)

Time range of deaths (days)

Overt toxicity

Weight change (g)

Male

1.25

0/5

-

-

 75 to 107 (mean 95)

2.5

2/5

0,5

Sluggish @ 10 mins; one death @ 15 mins.

 -31 to 108 (mean 61)

5.0

4/5

0,0,0,5

Sluggish and unsteady gait @ 2 mins; salivation @ 10 mins; death of 3 @ 6 min-2.5 h.

 125

 

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Not classified based on EU criteria
Conclusions:
A brief summary of a limited study, conducted according to a protocol that was similar to guideline but not compliant with GLP, recorded an LD50 in the rat of 2.97 ml/kg bw (approximately 3030 mg/kg bw).