Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-02-14 to 2012-04-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD guideline 402 and EU method B.3 in a GLP certified testing facility.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Sponsor’s identification: 400160
Batch No: KL-11-039
Purity: 100%
Container: glass flask (n=1)
Quantity: 65.83 g (container + contents)
Form: liquid
Colour: yellow
Storage: room temperature
Date received: 30 January 2012
Production date: 24 March 2011
Expiry date: 24 March 2016

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Sprague Dawley (SPF Caw) strain
Supplier: Elevage JANVIER (53940 Le Genest St Isle – France)
Number: 5 males (Rm9392 to Rm9396) and 5 females (Rf9397 to Rf9401)
Age at the beginning of the study: 8 to 9 weeks.
Body weights at the beginning of the study: 278-316 g (male) and 228-254 g (female)
Acclimatisation period: 5 d
Room temperature : 19-25 °C
Relative humidity: 30-70%
Light: artificial light from 7 a.m. to 7 p.m.
During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free weed shavings which were changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
Drinking water (tap-water from public distribution system) and foodstuff (M20-SDS) were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by IPL, Santé, Environnement Durables – Atlantique (Bordeaux).

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 h before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10% of the body surface area was clear for the application of BYK-400160.
Animals from treated group received by topical application, under porous gauze dressing, an effective dose of 2000 mg/kg body weight of BYK-400160 administered under a volume of 2.14 mL/kg body weight (corresponding to 2g/kg according to the calculated density), during 24 h. After 24 h exposure period, the gauze dressings were removed.
Duration of exposure:
The duration of exposure was 24 h.
Doses:
The test was performed as limit test with a single dose of 2000 mg/kg bw.
No. of animals per sex per dose:
5 male/5 female
Control animals:
yes
Details on study design:
Sacrifice: 14 d after administration of the test substance.
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died spontaneously during the experiment.
Clinical signs:
No systemic clinical sign related to the administration of the test item was observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Other findings:
No other findings were observed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The LD50 of 400160 is higher than 2000 mg/kg bw by dermal route in the rat. In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified. No signal word or hazard statement is required.
Executive summary:

The study has been performed according to OECD guideline 402 and EU method B.3 in a GLP certified testing facility. The test was performed as limit test.

Groups of young adult Sprague dawley rats (5 male/5 female) were dermally exposed to 400160 for 24 h to at least 10% of body surface area at a dose of 2000 mg/kg bw. Animals were observed for 14 days.

No mortality occurred during the study. No systemic clinical sign related to the administration of the test item was observed. The body weight evolution of the animals remained normal throughout the study. The macroscopically examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50of the test item 400160 is higher than 2000 mg/kg bw by dermal 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 400160 does not have to be classified. No symbol or risk phrase is required. In accordance with the Regulation EC No. 1272/2008, the test item does not have to be classified. No signal word or hazard statement is required.