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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