Resin acids and Rosin acids, barium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

ADAPTATION ACCORDING TO REACH ANNEX XI, section 1 - See attached justification for WoE: Acute oral toxicity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, calcium zinc salts

EC Number:

269-825-3

EC Name:

Resin acids and Rosin acids, calcium zinc salts

Cas Number:

68334-35-0

Details on test material:

Name of the test substance used in the study report: BREMAZIT 5060

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Young female adult animals (approx. 14- 18 weeks) with a comparable weight were used.
Acclimatization for at least 5 days.
Individual animal identification by cage cards and tail marking.
One animal per cage (type: stainless steel wire mesh cages, type DK-lll).
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity.
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum. Feed was withdrawn from the animais at least 16 hours before administration, but water was available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Olive oil Ph.Eur/DAB had to be used to ensure homogeneity of the preparation.
The test substance preparation was produced for each administration group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax ) and a magnetic stirrer.
Form of administration: suspension
Concentration used: 40 g/100 ml
Application volume: 5 ml/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

Observation period: at least 14 days
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
Necropsy with gross-pathological examination on the last day of the observation period after killing with CO2.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: No clinical observations were observed during clinical examination.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (6 females) examined at termination of the study.

Any other information on results incl. tables

RS-Freetext:
- No mortality occurred.
- No clinical signs and findings were observed.
- The mean body weights of the administration groups
  increased throughout the study period.
- No macroscopic pathologic abnormalities were noted in the
  animals examined at the end of the observation period.
- The median lethal dose of BREMAZIT 5060 after oral
  administration was found to be greater than 2,000 mg/kg
  body weight in rats.