Reaction mass of 2,2'-[methylenebis(2,1-phenyleneoxymethylene)]bis(oxirane) and 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]bis(oxirane) and 2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: In accordance with internationally valid GLP principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane

EC Number:

701-263-0

Cas Number:

9003-36-5

Molecular formula:

C6 H6. C3 H5 Cl . C H2 O)x

IUPAC Name:

Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane

Details on test material:

EPIKOTE 862

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

ANIMALS
Source: Charles River UK
Age: 9-11 weeks
Housing: singly in stainless steel cages
Food: ad libitum, PRD, Labsure Animal Foods, and water
Temperature: 19-25 degrees C
Lighting: 12 hour light dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

All animals were fasted for 18 hours prior to dosing. Dosing was by gavage using a ballpoint needle fitted to a syringe. After dosing the animals were given food and water ad libitum.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The test material was administered undiluted. Five rats of each sex were given doses of 5000 mg/kg.
Rats 9-11 weeks old at the time the test commenced. All animals were fasted overnight. Dosing was by gavage using a ballpoint needle fitted to a syringe. After dosing the animals were given food and water ad libitum and observed for clinical signs three times a day for the first three days and daily for the remainder of the 14 day observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: No deaths at the maximum dose

Mortality:

none

Clinical signs:

other: Most had piloerection and diarrhea on day 1. All rats had an unkempt appearance on subsequent days. Females recovered by day 4, but males did not recover until day 6.

Any other information on results incl. tables

Animal number and sex	Dose (mg/kg)	Body wt at day 1 (g)	Body wt at day 7 (g)	Body wt at day 14 (g)	Summary of signs and times of onset and recovery
643 F   644 F   645 F   646 F   647 F   643 M   644 M   645 M   646 M   647 M	5000   5000   5000   5000   5000   5000   5000   5000   5000   5000	140   135   167   144   135   191   211   206   181   199	161   152   158   163   155   204   239   237   205   225	172   161   167   171   155   229   256   258   226   246	Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-3 Recovered day 4. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6. Piloerection 3 h. No signs 3.5 h. Unkempt appearance days 2-5 Recovered day 6.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The acute oral LD50 of the test material in rats, administered undiluted, was greater than 5000 mg/kg.

Executive summary:

None of the rats died from which it was concluded that the acute oral LD50 of EPIKOTE 862, administered undiluted, was greater than 5000 mg/kg.

All rats were affected by the test material. Most had piloerection and diarrhea on day 1. All rats had an unkempt appearance on subsequent days. Females recovered by day 4, but males did not recover until day 6.All rats had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period.