Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002/07/12 - 2002/08/29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Tall-oil pitch
EC Number:
232-414-4
EC Name:
Tall-oil pitch
Cas Number:
8016-81-7
Molecular formula:
UVCB substance molecular formula unknown
IUPAC Name:
Tall-oil pitch
Details on test material:
- Name of test material (as cited in study report): Tall Oil Pitch

- Physical state: dark brown liquid

- Storage condition of test material: in the dark at ambient temperature

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 Lyd., Manston Rd., Margate, Kent, CT9 4LT

- Age at study initiation: 5-6 weeks

- Weight at study initiation: 104-131 g

- Fasting period before study: overnight

- Housing: The animals were housed indivifually in suspended cages (42x27x20cm) with stainless steel grid tops and solid bottoms. Wood shavings were used as bedding. Each cage was supplied with a water bottle and a metal food hopper. Cages, cage racks and water bottles were changed weekly during the study.

- Diet: Rat and Mouse No.1 Maintenance Diet, ad libitum, supplied by Special Diets Services Ltd., 1 Stepfield, Witham, Essex, CM8 3AD

- Water: from domestic mains supply, ad libitum

- Acclimation period: 4 weeks


ENVIRONMENTAL CONDITIONS

- Temperature (°C): max. 22C, min. 20C

- Humidity (%): 57

- Air changes (per hr): min. 15

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 4 ml/kg


- Rationale for the selection of the starting dose: The initial dose of 2000 mg/kg was chosen as this is the dose level suggested by the OECD Guideline. One animal was tested first, which survived and therefore 4 additional animals were dosed sequentially at 200 mg kg so that 5 animals were tested.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5F
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: All the animals were checked for viability frequently on the day of dosing and thereafter once each day. Clinical observations were conducted frequenrtly after dosing on Day 1 (at ca. 15min-30 min, 1h-1h 45min, 2h-2h 45min, 3h 15min-3h 45min and 4h 30min-5h 15min) and daily thereafter until Day 15. The body weight of each individual animal was recorded immediately before dosing (Day 1) and on Days 8 and 15.

- Necropsy of survivors performed: yes. All animals were terminated on Day 15 by exposure to CO2 followed by exsanguination.

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The necropsy consisted of an examination of the thoracic and abdominal organs and tissues in situ. Gross lesions were recorded in descriptive terms including location(s), size (in mm), shape, colour, consistency and number. Due to the size a mass noted on the thymus it was sent to to diagnostic pathology.
Statistics:
No formal statistical analysis was conducted.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities during the observation period.
Clinical signs:
No adverse clinical signs were noted during the observation period.
Body weight:
Body weight gain was considered to have been satisfactory.
Gross pathology:
One animal was noted to have an enlarged mediastinal lymph node and a mass on the thymus. This mass was found to be a mediastinal abcess at diagnostic pathology. These findings are considered to be procedural and not related to treatment.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute oral LD50 value of >2000 mg/kg was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.

Categories Display