Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited report, non GLP, no data on weight gain and no macroscopic evaluation. The information allows the derivation of an LD50. The information in the report is limited to the information in the summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FHSLA, CFR, Title 21, para. 191.1.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no iiformation on bodyweight gain, clinical signs and macroscopic investigations
Principles of method if other than guideline:
no report on bodyweight (end of study), no details on clinical findings and no macroscopy
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: not indicated
- Weight at study initiation: males: 200-218 g; females 203-217 g
- Fasting period before study: 18 hours
- Housing: individually
- Diet/water: no data

ENVIRONMENTAL CONDITIONS: no information available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:
2000 mg/kg bw (based on concentration in material)
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations and mortality check daily: weighing at the start of the study
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
NA

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
animals appeared healthy and normal
Body weight:
no data
Gross pathology:
not performed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test substance is > 2000 mg/kg bw
Executive summary:

In a limit test 5 rats/sex received 2000 mg/kg bw of the test substance by gavage. No mortality or clinical signs were observed during the 14 day observation period. The LD50 is > 2000 mg/kg bw.