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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
Study period:
26/10/2006 - 16/11/2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Organisation for Economic Co-operation and Development (OECD), OECD guidelines for Testing of Chemicals, Section 4; Health Effects. No. 423, "Acute Oral Toxicity - Acute Toxic Class Method", 2001
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
European Community (EC), Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, at last amended by Commission Directive 2004/73/EC, B.1 tris: "Acute Toxicity (Oral) - Acute Toxic Class Method", 2004
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870,1100, Acute Oral Toxicity. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-98-190, 2002
Qualifier:
according to
Guideline:
other: Notification 8147
Version / remarks:
Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder
Details on test material:
- Description: dark purple powder
- Solubility in the water: <= 0.412 g/L
- Melting point: > 250 °C
- Boiling point: > 250 °C
- Explosion: not explosion
- Log Pow: >= 3.3
- Test substance storage: at room temperature in the dark, 20°C, dry store
- Stability under storage conditions: stable

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Rat, Wistar strain Crl:WI (outbred, SPF-Quality). Recognised by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
using plastic feeding tubes
Doses:
single dosage, on Day 1
2000 mg/kg (10 ml/kg) body weight
300 mg/kg (10 ml/kg) body weight
No. of animals per sex per dose:
Number of animals: 9 females (nulliparous and non-pregnant). Each dose group consisted of 3 animals
Details on study design:
The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence of presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicty were taken into account for determinaton of the time interval between the dose groups.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Mortality:
The incidence of mortality was as follows, presented in chronological order of treatment:

Dose level Mortality Date of Treatment
2000 mg/kg 3/3 26 November 2006
300 mg/kg 1/3 31 November 2006
300 mg/kg 0/3 02 December 2006

The decedents were found between days 1 and 2 post-treatment.
Clinical signs:
Clinical signs observed during the study period were as follows:

Dose level Clinical signs
2000 mg/kg lethargy, hunched posture, laboured respiration, piloerection and ptosis
300 mg/kg lethargy, hunched posture, uncoordinatored movements, piloerections and ptosis

The surviving animals had recovered form the symptoms between days 2 and 3.
Body weight:
The body weights gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Other findings:
Microscopic findings: no abnormalities were found at macroscopic post mortem examinations of the animals.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The Oral LD50 value of SXJUL2006 in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.