Reaction mass of 2-(((1-(methacryloyloxy)propan-2-yl)oxy)carbonyl)benzoic acid and 2-((2-(methacryloyloxy)propoxy)carbonyl)benzoic acid

Endpoint summary

Description of key information

Acute oral toxicity study in female Wistar rats (Up/Down procedure)

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:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Age/Weight at dosing : 9 to 11 weeks, Weight (g) Minimum: 167.0, Maximum: 174.1
Source : Animal Breeding Facility, Jai Research Foundation
Total Number of Animals Used : Five females (nulliparous and non-pregnant)

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Single oral exposure

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

This study was conducted as a limit study with the dose level of 2000 mg a.i./kg body weight. The first rat was given a single dose of 2000 mg a.i. Methacryloxyisopropyl Acid Phthalate/kg body weight. No mortality was observed at this dose level up to 48 h post dosing. Therefore, rat N° 2, 3, 4 and 5 were treated with the same dose level of 2000 mg a.i. Methacryloxyisopropyl Acid Phthalate/kg body weight, one at a time, separated by minimum 48 h intervals. All rats survived at the dose level of 2000 mg a.i. Methacryloxyisopropyl Acid Phthalate/kg body weight, the end point was achieved and further testing was not required

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

None

Clinical signs:

No clinical signs

Body weight:

no BW observations

Gross pathology:

No abnormalities

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was estimated to be greater than 2000 mg a.i. Methacryloxyisopropyl Acid Phthalate/kg body weight in female Wistar rats.

Executive summary:

An acute oral toxicity study (Up-and-Down Procedure) was conducted using five female Wistar rats given a single oral dose of Methacryloxyisopropyl Acid Phthalate (Undiluted, as received). A limit Test was conducted with 2000 mg a.i./kg body weight. Doses were corrected for the purity of the material. The first rat survived; hence the four additional female Wistar rats each received a single dose of 2000 mg a.i./kg body weight according to the Up-and-Down Procedure. 

 

No sign of toxicity was observed in the rats treated with theMethacryloxyisopropyl Acid Phthalateat 2000 mg a.i./Kg body weight.

 

All rats were active and healthy during the study. All rats gained body weight by the end of the study period. 

 

External and visceral examination of terminally sacrificed rats did not reveal any lesions of pathological significance. In absence of any pathological lesion in terminally sacrificed animals, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.

 

The acute oral estimated LD₅₀of the Methacryloxyisopropyl Acid Phthalate was estimated to be greater than 2000 mg a.i./kg body weight in female Wistar rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Good

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Not classified

In the Acute oral toxicity study in femal wistar rats, no mortality and signs of toxicity were observed at 2000 mg a.i./kg bw/day. Therefore the LD50 is estimated to be > than 2000 mg/kg bw/day and the criteria for classification are not met.