Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
FROM 11 MAY 2009 TO 26 MAY 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 402/EU B3)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Licowax E
- Substance type: description: solid yellowish particulate (stated "powder" in study report), description at first use: light yellow particulate (stated "powder" in study report)
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy, San Pietro al Natisene, Italy
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 176-200 g
- Housing: individually in polycarbonate cages
- Diet (ad libitum): 4 RF 18 (Mucodela, Settimo Milanese, Italy)
- Water (ad libitum): drinking water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15-25
- Photoperiod (hrs dark / hrs light): 122/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: sesame oil
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 10% of body surface
- % coverage: semiocclusive
- Type of wrap if used: patch of surgical gauze covered by a strip of synthetic film, held in place by elastic adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbing of the treated area with cotton wool soaked with lukewarm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily for mortality and morbitity
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs: day of dosing (Day 1 of study): 1, 2 and 4 h after dosing, daily thereafter
body weight: day of allocation (day -1), day 1, day 8 and 15

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no
Clinical signs:
no
Body weight:
Changes in body weight were within the expected range at the end of study
Gross pathology:
no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
Single application of the limit dose of 2000 mg test substance (Licowax E) per kg bw did not cause lethality in male and female Sprague Dawley rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
Executive summary:

 

Female and male Sprague Dawley rats (5 per sex) were subjected to test acute oral toxicity. The test substance (Licowax E) was administered epicutaneously at the limit dose of 2000 mg/kg bw. No animal died during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

Therefore, the test substance has not to be classified for acute oral toxicity according to Regulation (EC) 1272/2008 and Council Directive 67/548/EEC.