Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12/2008 - 01/2009
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
other: Test method B.1ter Council regulation No 440/2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
The animals of the treated group 1, received an effective dose of 300 mg/kg body weight of the test item B 1061, diluted in distilled water and administered by gavage under a volume of 1.88 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
The animals of the treated group 2, received an effective dose of 2000 mg/kg body weight of the test item B 1061, administered pure by gavage
under a volume of 1.88 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
No. of animals per sex per dose:
Group 1 (300 mg/kg): 3 female rats Rf1689 to Rf1691 (Step 1)
3 female rats Rf1722 to Rf1724 (Step 2)
Group 2 (2000 mg/kg): 3 female rats Rf1846 to Rf1848 (Step 3)
3 female rats Rf1861 to Rf1863 (Step 4)
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No mortality occurred during the study.

No clinical signs related to the administration of the test item were observed.

The body weight evolution of the animals remained normal throughout the study.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

One animal presented with clinical signs, mainly a noisy respiration and a swollen abdomen, which were not attributable to the test item but to a problem during the gavage.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Executive summary:

The test item B 1061 was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 300 mg/kg body weight and then to a group of 6 Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocoll was established on the basis of the official method as defined in the O.E.C.D. guideline N°423 dated 17. Dezember 2001 and the test method B.1ter of the Council regulation No. 440/2008.

No mortality occurred during the study.

No clinical signs related to the administration of the test item B 1061 were observed.

The body weight evolution of the animals remained normal throughout the study.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item B 1061 is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the O.E.C.D. guideline N° 423, the LD50 of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the

E.E.C. Directives 67/548, 2001/59 and 99/45, the test item B 1061 doesn't need to be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (Regulation (EC) No. 1272/2008), the test item B 1061 doesn't need to be classified in category 4. No signal word and hazard statement are required.