Ricinoleyl monomaleate triglyceride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23-07 to 07-08-1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Castor Oil/Maleic Anhydride Adduct CAS# 10502-43-12
- Date received: 16 June 1998
- Description: clear yellow liquid
- Specific gravity: 1.03

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace animals, Boyertown, PA on 7/7 and 14/7/1998
- Quarantine period of at least one week.
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: males: 217 - 230 g; females: 211 - 235 g
- Fasting period before study: 16-20 h
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5012)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 to 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:

other: By syringe and dosing needle.

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2, 4 h and daily for 14 days (twice daily for mortality)
- Frequency of weighing: before dosing and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels: No deaths occurred. No clinical signs reported in the main study in the 5 males and 5 females other than diarrhea and soiling which is considered consistent with large doses of oily materials.

Body weight:

Body weights were normal.

Gross pathology:

Effects on organs: No effects on organs reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU