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

Endpoint summary

Description of key information

Acute oral toxicity (rat): LD50 > 2000 mg/kg.

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:

04 September 2003 - 27 October 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted in accordance with international guidelines.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 weeks
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: PEG300

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2g/mL (200 mg/mL)
- Justification for choice of vehicle: The vehicle was chosen after a non GLP solubility trial which was performed before the study initiation date.
PEG300 was chosen to be a suitable vehicle.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

Single dose of: 2000 mg/kg

No. of animals per sex per dose:

6 (2 groups of 3)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: mortality/viability, clinical signs, body weight

Statistics:

No statistical analysis was used.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occured during the study.

Clinical signs:

No clinical signs were observed during the course of the study.

Body weight:

The body weight of the animals was within the range commonly recorded for this strain and age.

Gross pathology:

No macroscopic findings were recorded at necropsy.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of ADEKA RESIN EP-4000S after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

A reliable study (GLP-compliant study conducted according to official international test guidelines) is available; the available result is considered satisfactory to meet the data requirement for this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

An acute oral toxicity study was conducted (RCC Ltd, 2003) to assess the effect of EP-4000S following a single oral administration of the test substance to rats. The study was conducted in compliance with GLP and according to EC and OECD test guidelines. Rats were dosed according to the acute toxic class method, and were observed for 14 days after administration.

The highest dose level assessed was 2000 mg/kg; no deaths were observed at this level and no signs of toxicity were found. The acute median lethal dose (LD₅₀) to rats was found to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

The acute LD₅₀ by oral administration to rats for EP-4000S was found to be greater than 2000 mg/kg; the substance does not meet the criteria for classification as acutely toxic by oral administration (CLP Regulation or Dangerous Substances Directive criteria).

No signs of toxicity were observed in the acute oral toxixicty test; there is therefore no indication of specific target organ toxicity.