Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (analytical purity of the test substamce, humidity and temperature are not specified in the study report)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
analytical purity of the test substamce, humidity and temperature are not specified in the study report
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Acrawax C
- Analytical purity: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gota-Frisco Farms
- Age at study initiation: young adult, not further specified
- Weight at study initiation: 2.0 - 3.0 kg, weight variation did not exceed ± 20 % of the group mean of each sex
- Housing: Individually housing in suspended stainless steel wire mesh bottom cages, conform to AAALAC standards and those published in the "Guide for the care and use of laboratory animals" NIH publication No. 85-23
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 12 x 20 cm
- % coverage: 10 %
- Type of wrap if used: A tubular stockinette sleeve and an adjustable harness were placed around the animal’s trunk. Nonirritating tape was used to secure both the gauze dressing and stockinette sleeve.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes, the dressing was moistened with distilled water at a rate of 1 mL/g of test article to ensure good contact of the test article with the skin


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
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 and weighing: The animals were observed for pharmacotoxic signs three times on the day of dosing and once daily thereafter for the duration of the study (15 days). Mortality checks were performed twice daily, a minimum of 5 hours apart. Individual body weights were determined and recorded on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Histopathology: At study termination (day 15), the heart, kidneys, liver, lungs and stomach were excised from each animal and preserved. After complete fixation, the liver and kidneys from each rabbit were embedded in paraffin, sectioned at 3-5 mm in thickness, stained with hematoxylin and eosin, and then examined microscopically by an SIB Pathologist.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived until scheduled sacrifice.
Clinical signs:
No clinical signs of toxicity were noted during the study.
Body weight:
No treatment related body-weight changes were noted during the study.
Gross pathology:
Necropsy examinations revealed the kidneys of two males to have a pitted capsular surface. No other gross abnormalities were noted.
Other findings:
- Histopathology: Microscopic examination of the liver revealed minimal chronic multifocal inflammation in three animals (one male and two females) and minimal acute exudative multifocal inflammation in one animal (male). In three of the ten test animals, chronic multifocal inflammation of the liver and kidneys occurred together.

- Other observations: The occurrence of the above pathological findings cannot be definitely attributed to treatment with the test article as similar lesions are commonly seen at this incidence level in the liver and kidneys of untreated stock laboratory rabbits.

Any other information on results incl. tables

Acrawax C is judged to be nonlethal and nontoxic when administered by the dermal route at 2000 mg/kg body weight to New Zealand albino rabbits.

Acrawax C does not have to be classified for acute toxicity via the dermal route according to the criteria laid down in Regulation (EC) 1272/2008 and Directive 67/548/EEC.

Applicant's summary and conclusion