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: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal 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

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

All animals had 60% of their dorsal hair removed the day prior to dosing. A 2000 mg/kg dosing was applied by syringe and covered with gauze and held in place with elastic tape. Rats were individually housed and given water ad libitum for 24 hours before the removal of the dressing and washing of the skin.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

All animals had 60% of their dorsal hair removed the day prior to dosing. A 2000 mg/kg dosing was applied by syringe and covered with gauze and held in place with elastic tape. Rats were individually housed and given water ad libitum for 24 hours before the removal of the dressing and washing of the skin. After dosing the animals were 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:

> 2 000 mg/kg bw

Remarks on result:

other: No mortalities were observed at the maximum dose

Mortality:

none

Clinical signs:

other: none

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 7 (g)	Summary of signs and times of onset and recovery
648 F   649 F   650 F   651 F   652 F   648 M   649 M   650 M   651 M   652 M	2000   2000   2000   2000   2000   2000   2000   2000   2000   2000	150   151   155   154   166   244   193   202   201   199	150   150   158   160   167   249   191   199   199   199	167   159   169   168   177   269   212   215   218   224	No signs seen.   No signs seen.   No signs seen.   No signs seen.   No signs seen.   No signs seen.   No signs seen.   No signs seen.   No signs seen.   No signs seen.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The acute dermal LD50 of the test material in rats, administered undiluted, was greater than 2000 mg/kg.

Executive summary:

None of the rats died from which it was concluded that the acute dermal LD50 of EPIKOTE 862, administered undiluted, was greater than 2000 mg/kg.

No clinical signs were observed during the study. All rats had gained weight relative to their day 1 bodyweights by the end of the 14 day observation period.