complex reaction mass of Chinese gum rosin post reacted with acrylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 July 1998 - 20 August 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

starting dose was 200 mg/kg bw (recommended dose: 300 mg/kg bw)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): ARAKAWA KE-604
- Physical state: pale yellow blocks
- Analytical purity: no data
- Lot/batch No.: R61132
- Storage condition of test material: room temperature in the dark

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 Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Males: 202-241 g, females: 202-220 g
- Fasting period before study: overnight before dosing and for approx. 3-4 h after dosing
- Housing: in groups up to three by sex in solid floor polypropylene cages with woodflakes bedding.
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diets Services Ltd, Witham, Essex, UK
- Water (e.g. ad libitum): mains drinking water
- Acclimation period:at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 49-64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

EXPERIMENTAL DATES: The study was performed between 28 July 1998 and 20 August 1998.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Test substance was not water soluble

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
No toxicity data were available, therefore a starting dose of 200 mg/kg in females was used.

Doses:

200 mg/kg bw (starting dose) and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed 0.5, 1, 2, 4 hours after dosing and once daily thereafter.
Body weights were recorded on Day 0 (day of dosing), 7 and 14, or at death.
- Necropsy of survivors performed: yes, all animals.
- Other examinations performed: clinical signs of systemic toxicity

Statistics:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

One female rat dosed at 2000 mg/kg bw was found dead one day after dosing.
No mortalities occured at 200 mg/kg bw.

Clinical signs:

Hunched posture, pilo-erection, decreased respiratory rate and laboured respiration were noted in the two surviving females dosed at 2000 mg/kg bw. No signs of systemic toxicity were noted in all other treated animals throughout the study.

Body weight:

All surviving animals showed the expected gain in bodyweight over the study period.

Gross pathology:

No abnormalitites were noted at necropsy of all animals killed at termination of the study.
In the female animal that died during the study, haemorrhagic lungs, dark liver, dark kidney and slight haemorrhage of the gastric mucosa were noted.

Any other information on results incl. tables

In an acute oral toxicity study (acute toxic class method according to OECD Guideline 423) fasted male and female (6/6) Sprague-Dawley CD rats were administered with 200 (starting dose) and 2000 mg/kg bw of the test substance ARAKAWA KE-604 in arachis oil.

No mortalities and no clinical signs of systemic toxicity occured at 200 mg/kg bw. One female rat dosed at 2000 mg/kg bw was found dead one day after dosing. Hunched posture, pilo-erection, decreased respiratory rate and laboured respiration were noted in the two surviving females dosed at 2000 mg/kg bw. No signs of systemic toxicity were noted in all other treated animals throughout the study. The acute oral LD(50) was calculated to be > 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information No classification or labelling is required according to EU classification criteria. Criteria used for interpretation of results: EU