Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 Oct 2014 to 10 Nov 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to the guidelines, under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): EnvaMul™200
- Substance type: UVCB
- Physical state: Dark brown, opaque, viscous liquid
- Analytical purity: UVCB 100%
- Lot/batch No.: 042313
- Stability under test conditions: stable
- Storage condition of test material: oom temperature, protected from light
- Expiry date: 23 -Apr-2015

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: Males 322-340 g; Females 217-266 g
- Fasting period before study: NA
- Housing: individually in stainless steel, wire-mesh cages suspended above cage-board
- Diet: PMI Nutrition International, LLC, Certified Rodent LabDiet ® 5002 ad libitum
- Water: Municipal water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3ºC to 21.4ºC
- Humidity (%): 34.8% to 49.2%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Details on dermal exposure:
TEST SITE
- Area of exposure, coverage: 10% of body surface
- Type of wrap if used: gauze binders (<8 ply) that were secured with nonirritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.01 mL/kg, 2000 mg/kg bw (density 0.997)

VEHICLE: none
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males + 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality 1, 2, and 4 hours post-application on study day 0 and twice daily thereafter
- Necropsy of survivors performed: yes (macroscopy)
- Other examinations performed:
clinical signs: 1, 2, and 4 hours post-application on study day 0 and daily thereafter (includes signs of irritation)
body weight: on day 0, 7 and 14
Statistics:
NA

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
no treatment related effects (no signs of irritation, brown discoloration of the application site)
Body weight:
within normal ranges
Gross pathology:
no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the substance after dermal application is > 2000 mg/kg bw.
Executive summary:

Rats (5/sex) were treated dermally with 2000 mg/kg bw of the test substance. No mortality, effects on body weight, abnormal clinical observations or macroscopic effects were found in the 14 days observation period. The LD50 is therefore > 2000 mg/kg bw.