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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-08 to 21-08-1998
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 798.1100 (Acute Dermal 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:
rabbit
Strain:
New Zealand White
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: 2 to 4 months
- Weight at study initiation: males: 2.2 - 2.7 kg; females: 2.0 - 2.4 kg
- Fasting period before study: not applied
- Housing: 1/cage
- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5321)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 to 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Day prior to application of the test article, the dorsal area of the trunk (10% of body surface) of each animal was clipped free of hair.
- Coverage: four layer surgical gauze patch 10 x 15 cm
- Type of wrap if used: plastic wrap with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle with destilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
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:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: No deaths occurred. No signs of systemic toxicity
Body weight:
Normal increase in body weight.
Gross pathology:
Effects on organs: No effects reported
Other findings:
Signs of toxicity (local):
All animals showed local effects after 24 hours with erythema scores of 1 and 2 and edema scores of 1, 2 and 3 recorded. There was no edema reported by day 7. Erythema scores with flaking skin of 1 and one of 2 were observed after 7 days, with all animals appearing healthy after 14 days.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU