Condensation products of oil shale alkylresorcinols and formaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 March 2004 and 21 April 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

447-830-3

EC Name:

-

Molecular formula:

Not applicable to this UVCB substance.

IUPAC Name:

2-ethylphenol; 3,5-dimethylphenol; formaldehyde; phenol

Test material form:

other: solid resin

Details on test material:

- Date received: 30 January 2004
- Storage conditions: room temperature in the dark, under nitrogen

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 193 - 209 g
- Fasting period before study: overnight fast immediately before dosing and 3 to 4 hours ater dosing
- Housing: animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): free access to certified rat and mouse feed
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: at least five days
- Other: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

IN-LIFE DATES: From: 30 March 2004 To: 21 April 2004

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 bw
- Justification for choice of vehicle: material does not dissolve in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg (the volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing)

DOSAGE PREPARATION:
For the purpose of the study the test material was ground to a powder and then freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil BP. Arachis oil BP was used because the test material did not dissolve/suspend in distilled water.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: material not expected to be toxic

Doses:

single

No. of animals per sex per dose:

6 (two groups of 3 animals)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None of the animals died during the study.

Clinical signs:

other: Signs of systemic toxicity noted during the study were hunched posture, increased salivation, pilo-erection, noisy respiration and red/brown staining around the mouth. Animals appeared normal one or two days after dosing.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The study used 6 female rats and followed the actute toxic-class method, in accordance with the OECD 423 guideline. The study was conducted to GLP standard in a certified laboratory.

All clinical signs observed had disappeared within 2 days. Bodyweight gain remained normal and no abnormalities were revealed at necrospy. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.