Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-01-03 - 2017-01-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
other: CD / Crl: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Males: approx. 8 weeks, Females: approx. 9 weeks

- Weight at study initiation: Males: 228 - 245 g, Females: 219 - 234 g

- Fasting period before study: approximately 16 hours before administration
- Housing:singly in MAKROLON cages
- Diet: ad libitum)
- Water; ad libitum
- Acclimation period:At least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55%± 15%
- Photoperiod (hrs dark / hrs light): 12 hours each

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Sesame oil/Ethanol
Details on dermal exposure:
The intact dorsal skin of the animals was shaved free of hair with a shaver approximately 24 hours before administration of the test item. The site was situated on the animal´s back between the fore and hind extremities and had an area of at least 5 cm x 6 cm (approx. 1/10 of body surface).
The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site for 24 hours.
Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
1 dose level group of 5 males and 5 females
Control animals:
no

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
Clinical signs:
no
Body weight:
no
Gross pathology:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, a single dermal administration of 2000 mg Ukanol FR 70/kg b.w. did not reveal any signs of toxicity nor skin reactions at the application site. All animals gained the expected body weight. No animal died prematurely.
LD50 value for males and females combined (14 days):
> 2000 mg Ukanol FR 70/kg b.w.
According to the EC Regulation 1272/2008 and subsequent regulations, the test material does not require classification for acute dermal toxicity.
Also according to the Globally Harmonized Classification System (GHS) the test item requires no labelling (as LD50 > 2000 mg/kg b.w.).
Executive summary:

Under the present test conditions, a single dermal administration of 2000 mg Ukanol FR 70/kg b.w. did not reveal any signs of toxicity nor skin reactions at the application site. All animals gained the expected body weight. No animal died prematurely.

LD50value for males and females combined (14 days):

            > 2000 mg Ukanol FR 70/kg b.w.

According to the EC Regulation 1272/2008 and subsequent regulations, the test material does not require classification for acute dermal toxicity.

Also according to the Globally Harmonized Classification System (GHS) the test item requires no labelling (as LD50> 2000 mg/kg b.w.).