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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-hydroxyethyl) (6H-dibenz[c,e][1,2]oxaphosphorin-6-ylmethyl)succinate P-oxide

EC Number:

264-313-6

EC Name:

Bis(2-hydroxyethyl) (6H-dibenz[c,e][1,2]oxaphosphorin-6-ylmethyl)succinate P-oxide

Cas Number:

63562-34-5

Molecular formula:

C21H23O8P

IUPAC Name:

Butanedioic acid, 2-​[(6-​oxido-​6H-​dibenz[c,​e]​[1,​2]​oxaphosphorin-​6-​yl)​methyl]​-​, 1,​4-​bis(2-​hydroxyethyl) ester

Test material form:

liquid: viscous

Test animals

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.

Administration / exposure

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

Results and discussion

Effect levels

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

Applicant's summary and conclusion

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.).