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Toxicological information

Acute Toxicity: oral

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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:
other: Basic data given (analytical purity of test substance not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(analytical purity of test substance not specified)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tween 61
- Physical state: tan solid
- Lot/batch No.: 211

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Manor Farms Research, Inc.
- Weight at study initiation: 150 g (141-157 g)
- Fasting period before study: 16 h
- Diet: ad libitum after dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
, but melted to approximately 40°C
Doses:
35500 and 39800 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: at intervals during the first six hours after dosing and daily thereafter up to the 14th day
- Necropsy of survivors performed: yes (adrenals, bladder, liver, spleen, stomach, kidneys, lungs, thymus, heart, small and large intestine)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 39 800 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
Most of the animals had diarrhea:
39800 mg/kg:
2/10 at 19 hours, 4/10 at 21 hours, 9/10 (2/10 slight degree) at 24 hours, 4/10 at 48 hours
35500 mg/kg:
10/10 within 22 hours through 24 hours, 3/10 slight degree at 48 hours
Gross pathology:
The following effects were observed:
39800 mg/kg:
bladder: 3/10 distended with urine
heart: 2/10 soft
kidneys: 4/10 (2/4 slight) hydronephrosis
lungs: 3/10 focal hemorrhage, 2/10 slightly congested

35500 mg/kg:
bladder: 2/10 (1/2 slight) distended with urine
heart: 5/10 (1/5 slight) soft
kidneys: 5/10 (1/5 slight) hydronephrosis

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified