Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Apr - 17 Apr 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1998
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted in 2008
GLP compliance:
yes (incl. certificate)
Remarks:
GYEMSZI, National Institute for Quality- and Organizational Development in H ealthcare and Medicine, Budapest, Hungary
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CRL:(WI)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adults
- Weight at study initiation: 214 - 258 g (males and females)
- Housing: individual caging in type II polypropylene/polycarbonate cages, "Lignocel Hygienic Animal Bedding" (J. Rettenmaier & Söhne GmbH+Co.KG, Rosenberg, Germany)
- Diet: ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" (ssniff Spezialdiäten GmbH, Soest, Germany) ad libitum
- Water: tap water from the municipal supply ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 - 25
- Humidity (%): 32 - 50
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 5 cm² shorn skin of the dorsal area of the trunk
- % coverage: 10%
- Type of wrap: the test material was held in contact with the skin by gauze pads dampened with water to ensure good contact with the skin. An adhesive hypoallergenic plaster kept the gauze pads in contact with the skin. The entire trunk of the animals was then wrapped with semiocclusive plastic wrap for 24 h.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed with water at body temperature.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Constant concentration used: yes
- For solids, paste formed: no
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males per male dose group and 5 females per female dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed at 1 and 5 hours after the application of the test item and daily thereafter; body weight was recorded at the beginning of the experiment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic appearance of organs and tissues
Statistics:
Mean and standard deviation of the body weight and body weight gain were calculated.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
2000 mg/kg bw: body weight gains were within the normal ranges in males and females during the whole study period.
Gross pathology:
2000 mg/kg bw: necropsy examination revealed no substance-related findings.

Applicant's summary and conclusion

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