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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:
comparable to guideline study with acceptable restrictions
Remarks:
Limited data on materials and method, test substance purity not specified.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Report Date:
1983
Reference Type:
secondary source
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
yes
Remarks:
limited data on materials and method, test substance purity not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, USA
- Weight at study initiation: 350.0 g (males), 174.0 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: individual, in wire mesh bottom cages
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
Animals were housed in environmentally controlled rooms.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 8.20 mL (males), 3.96 mL (females)
Doses:
20 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: animals were observed for clinical signs 'frequently' on the day of administration and daily thereafter; body weight was recorded on Day 1 (prior to administration) and Day 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the 15-day observation period.
Clinical signs:
5/5 males and 5/5 females had diarrhoea 1 and 4 h after administration. On Day 2, 2/5 females had apparent urinary incontinence, one of these females also showed decreased activity. 1/5 females had soft stool on Day 2. No clinical signs were observed from Day 3 onwards.
Body weight:
Body weight gain in males and females were within the range expected for rats of this strain and age used in this type of study.

Gross pathology:
No substance-related findings were observed at the necropsy and histopathological examination.

Any other information on results incl. tables

Table 1. Acute oral toxicity

Dose

[g/kg bw]

Mortality

Clinical signs

 

N*

N*

Males

20

0/5

5/5

Females

20

0/5

5/5

*N= Number of animals/ number of animals used

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.