Oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 May to 29 August 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in accordance with internationally recognised guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000.

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

460-230-6

EC Name:

-

Cas Number:

36484-54-5

IUPAC Name:

Oligomeric reaction products of 4,4'-propane-2,2-diyldiphenol and 2-methyloxirane and 2-(chloromethyl)oxirane

Test material form:

other: liquid

Details on test material:

- Name of test material: Aliphaticdiol diglycidyl ether
- Physical state: liquid
- Analytical purity: 99%
- Lot/batch No.: 20481
- Expiration date of the lot/batch: 01 April 2018

Test animals

Species:

rat

Strain:

other: RccHan®:WIST albino rats

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: reputable supplier
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 152 to 173 g
- Housing: singly for sighting investigations and in groups of four rats of the same sex for the main study..
- Diet: free access to standard rodent diet except for overnight prior to and approximately four hours after dosing.
- Water: free access to water from the public supply
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): continuous supply inder positve pressure
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours continuous dark per 24 hours

IN-LIFE DATES: From: 28 May To: 23 June 2015

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

1 - sighting investigation
4 - main study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: the macroscopic appearance of the brain, caecum,
duodenum, heart, kidneys, small and large intestine, liver, lungs and bronchi, spleen, stomach, subcutaneous tissue and urinary bladder was recorded

Results and discussion

Preliminary study:

No deaths or clinical signs. Satisfactory bodyweight gain. No abnormalities observed during macrospopic examination

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study.

Clinical signs:

Piloerection was seen in one female dosed at 2000 mg/kg. This sign was first noted on Day 2. Recovery, as judged by external appearance and behaviour, was complete by the end of Day 2. No clinical signs were seen for any other animal.

Body weight:

All animals were considered to have achieved satisfactory body weight gains throughout the study.

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal oral dose (LD50) to rats of Aliphaticdiol diglycidyl ether was demonstrated to be greater than 2000 mg/kg body weight.