MMCT

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Mar - 05 Apr 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2004

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

adopted in 2002

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HsdCpb:Wu

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% Cremophor EL

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females per step

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: cut-off value

Mortality:

No mortality occurred during the study period.

Clinical signs:

Clinical signs were observed in all animals and comprised decreased motility in 6/6 rats, uncoordinated gait in 6/6 rats, piloerection in 5/6 rats, abdominal position in 5/6 rats, labored breathing in 1/6 rats and increased water intake in 6/6 rats. All effects were fully reversible until study Days 8 (first dosing step) and 9 (second dosing step).

Body weight:

All animals gained weight as expected.

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings.

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.

Conclusions:

Oral administration of 2000 mg/kg bw test substance did not induce mortality in female rats. Clinical signs of toxicity were observed in all animals and comprised decreased motility, uncoordinated gait, piloerection, abdominal position, labored breathing and increased water intake. There was no impairment of body weight development and no gross and histopahtological abnormalities. The LD50 value was > 2000 mg/kg bw. No classification is required according to CLP/EU GHS criteria.