REAKTIV OLIV F00-149

Endpoint summary

Description of key information

An acute oral and dermal toxicity study were performed following GLP guidelines and in accordance with OECD 423 and EU Method B.1. (oral) and OECD 402 and EU Method B.3 (dermal). 

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:

2001-12-13 to 2002-03-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

96/54/EG, B.1tris (Akute-toxische-Klassen-Methode); OECD 423

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: Males=204g; Females=199g
- Housing: in transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days
- Fasting period before study: fasted before receiving dose

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: received the compound as a 20 % suspension in deionized water
- Amount of vehicle (if gavage): 10 mL/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: symptoms observed twice daily, once on weekends and public holidays; animals weighed weekly
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg body weight; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg body weight; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: No clinical symptons were observed after the application of the testing substance.

Gross pathology:

No gross pathology changes

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median LD50 (oral) of Reactive Olive F00-0149 for male and female rats is >2000 mg/kg body weight.

Executive summary:

In an acute oral toxicity study, groups of 3 animals/sex of HSD Sprague Dawley Rats aged 6-10 weeks, were given a single oral dose of Reactive Olive F00-0149 in deionized water at a doses of 2000 mg/kg body weight and observed for 14 days.

 

Oral LD50

Male = >2000 mg/kg body weight

Female = >2000 mg/body weight

Combined = >2000 mg/kg body weight

 

Reactive Olive F00-0149 is of Low toxicity based on the LD50 in male and female rats

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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:

2002-01-16 to 2002-03-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: M=252g; F=205g
- Housing: in transparent macrolon cages (type III) on soft wood granulate in an air-conditioned room, 1 animal per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 30 cm²
- Type of wrap if used: The appropriate amount of the test substance was moistened on a two-ply gauze and an aluminum foil (6 x 8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administered to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal's body.

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

TEST MATERIAL
- Concentration (if solution): 0.5 g Reaktiv Oliv F00-0149 was moistened with 0.3 mL deionized water.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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 and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg body weight; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No clinical symptoms were observed.

Gross pathology:

No gross pathology changes

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median LD50 (dermal) of Reactive Olive F00-0149 for male and female rats is >2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study, HSD Sprague Dawley rats, 5/sex, were dermally exposed to Reactive Olive F00-0149 in deionized water for 24 hours to 30 cm² of body surface area at a dose of 2000 mg/kg body weight. Animals then were observed for 14 days.

Dermal LD50:

Males = >2000 mg/kg body weight

Females = >2000 mg/kg body weight

Combined = >2000 mg/kg body weight

Reactive Olive F00-0149 is of LOW Toxicity based on LD50 > 2000 mg/kg body weight.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Male and female Sprague Dawley rats were dosed via gavage with Reactive Olive F00-0149 in deionized water at 2000 mg/kg body weight. The resulting LD50 is >2000 mg/kg bw. The test substance did not induce any toxic effects regarding clinical signs, morphologic changes, or body weight.

Male and female Sprague Dawley rats were dermally exposed to 2000 mg/kg bw of Reactive Olive in deionized water. The LD50 in both sexes was >2000 mg/kg bw. The test substance did not induce any substance-related effects.

Justification for selection of acute toxicity – oral endpoint
OECD 423 GLP guideline study.

Justification for selection of acute toxicity – dermal endpoint
OECD 402 GLP guideline study

Justification for classification or non-classification

No adverse effects were observed in an acute oral and dermal toxicity study, performed according to OECD guidelines and following GLP.