Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 29 - November 12, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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 (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SAGE Labs
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 267-286 g males, 179-195 g females
- Housing: Singly in suspended stainless steel cages.
- Diet: Envigo Teklad Global 16% Protein Rodent Diet #2016, ad libitum
- Water: Filtered tap water, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-61
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: October 29, 2015 To: November 12, 2015

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 2 x 3 inches (approx. 5 x 7.5 cm)
- % coverage: 10% of body area
- Type of wrap if used: Gauze pad covered by Durapore tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Washed with 3% soap solution followed by tap water.
- Time after start of exposure: 24 hrs.

TEST MATERIAL
- Treatment of test material prior to testing: Test substance was ground and passed through 425 micron sieve.
- Concentration (if solution): 60% (w/w) test substance/water
- Constant volume or concentration used: yes
- For solids, paste formed: yes



Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for several hours after dosing, and then at least daily thereafter. Weighing was performed on Day 0, Day 7, and Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Not used.

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 was seen during the study.
Clinical signs:
All animals appeared active and healthy during the study.
Body weight:
All animals gained weight as expected during the study.
Gross pathology:
No abnormalities were noted during necropsy.
Other findings:
- Histopathology: No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The acute dermal LD50 is > 2000 mg/kg bw. The test substance is not toxic by the dermal route.
Executive summary:

5 male and 5 female rats were exposed to a dose of 2000 mg/kg bw of the test substance Sucrose Palmitate Stearate MDT Grade dermally for 24 hrs under occlusive conditions. The animals were observed for 14 days after the end of exposure. No mortality was observed in the test animals, nor any other adverse effects. The acute dermal LD50 is > 2000 mg/kg bw.