Reaction product of 6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide, itaconic acid and ethylene glycol

Endpoint summary

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system 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:

other: 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.

Clinical signs:

other:

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

male/female

Details on test animals or test system 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:

other: 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.

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.