Ricinoleyl monomaleate triglyceride

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

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.

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.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

High: LD50 > 5000 mg/kg bw.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

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.

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.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

High: LD50 > 2000 mg/kg bw.

Additional information

Justification for selection of acute toxicity – oral endpoint
Key study.

Justification for selection of acute toxicity – dermal endpoint
Key study.

Justification for classification or non-classification

Not classified.