4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 16 to July 08, 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no data about purity and no certificate of analysis of the test substance

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid

EC Number:

500-130-2

EC Name:

4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid

Cas Number:

55818-57-0

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Reaction product of (4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane) and 2-propenoic acid

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: Males: 142-174 g, females: 134-155 g
- Fasting period before study: Overnight
- Housing: Housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, UK), ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 47-75%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

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

DOSAGE PREPARATION (if unusual): Test material was freshly prepared as a suspension in arachis oil B.P. The preparation was heated to approximately 70 °C in water to ensure adequate mixing and allowed to cool before dosing.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose was selected based on a range-finding study conducted on 1 rat/sex/dose at 2000 mg/kg bw and animals were observed for 5 days.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and overt signs of toxicity were recorded at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days; individual bodyweights were recorded on Day 0 (prior to dosing), 7 and 14
- Necropsy of survivors performed: Yes; surviving animals were killed by cervical dislocation and examined grossly

Statistics:

No

Results and discussion

Preliminary study:

In the range-finding study, no mortality or clinical signs of toxicity were observed (only one rat treated with 2000 mg/kg).

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths were observed .

Clinical signs:

other: Animals appeared normal throughout the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for DGEBA diacrylate is higher than 2000 mg/kg bw in rats therefore it is not classified for oral acute toxicity.

Executive summary:

In an acute oral toxicity (limit test) study performed in accordance with GLP and OECD guideline 401, groups (5/sex) of Sprague-Dawley rats were given a single oral dose of DGEBA diacrylate in arachis oil at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all macroscopically necropsied after sacrifice. A preliminary range-finding test was also conducted on 1 rat/sex/dose at 2000 mg/kg bw and animals were observed for 5 days. In this previous test, no mortality or clinical signs of toxicity were observed.

In the main study, no deaths were observed and animals appeared normal throughout the study period. All animals showed expected gain in bodyweight over the study period. No abnormalities were noted at necropsy. The combined oral LD50 was considered to be greater than 2000 mg/kg bw.