Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: A single oral administration of 2000 mg Ukanol FR 70/kg b.w. did not reveal any signs of toxicity. All animals gained the expected body weight. No animal died prematurely.No pathological changes were observed at necropsy. LD50value: > 2000 mg Ukanol FR 70/kg b.w.

Acute dermal toxicity: 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.

Acute toxicity by inhalation: Dust formation is unlikely since the substance has an amorphous glass-like character. Therefore no further testing is necessary.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-12-23 - 2017-01-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: CD / Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 180 - 207 g
- Fasting period before study: 16 hours before administration
- Housing:in groups of 3 animals 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): rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil/Ethanol
Details on oral exposure:
Administration volume 20 mL/kg b.w.

Doses:
Dose level 2000 mg/kg b.w. (limit test)
No. of animals per sex per dose:
6
Control animals:
no
Key result
Sex:
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
Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, a single oral administration of 2000 mg Ukanol FR 70/kg b.w. did not reveal any signs of toxicity. All animals gained the expected body weight. No animal died prematurely. No pathological changes were observed at necropsy.
LD50 value: > 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 oral 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 oral administration of 2000 mg Ukanol FR 70/kg b.w. did not reveal any signs of toxicity.All animals gained the expected body weight.No animal died prematurely.No pathological changes were observed at necropsy.

LD50value:         > 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 oral toxicity.

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A GLP-study is available.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. DOP-ITS-Glycolic ester is used exclusively in glycolic solution where
formation of aerosols is not possible. Furthermore dust formation is unlikely since the substance has an amorphous glass-like character. Therefore no further testing is necessary.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Dust formation is unlikely since the substance has an amorphous glass-like character. Therefore no further testing is necessary.

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
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
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
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.).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A GLP-study is available.

Additional information

Justification for classification or non-classification

The respective GHS-criteria are not met.

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