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Registration Dossier
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EC number: 807-619-2 | CAS number: 65535-29-7
Endpoint summary
Administrative data
Description of key information
The acute toxicity (LD50) of epoxide valerate in rats is > 2000 mg/kg bw after oral administration (Rusch and Flowers, 1991) and after dermal application (Kurth, 1996).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb to Apr 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Commission Directive no. 79/831 EEC of.18. September 1979 (equivalent to the corresponding German regulations)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- study was conducted prior to implementation of OECD TG 423
- GLP compliance:
- yes
- Remarks:
- - but a QA check was not performed
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: males: 102-115 g; females: 89-91 g
- Fasting period before study: Males ca. 20.25 h, females ca. 18.5 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): pell. Altromin R ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50-76
- Route of administration:
- oral: gavage
- Vehicle:
- other: 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidest water
- Doses:
- 2000 mg/kg
- 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: Day 1 at 30 min, 1 h, and 3 h after dosing, day 2-14. Body weight at day 1, 7, 8 and 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight: apathy, slight; diarrhea, slight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died in the course of the study.
- Clinical signs:
- other: The administration of 2000 mg/kg bw provoked slight apathy in two females as well as slight diarrhea in one female on application day 1. All animals were without any clinical findings from day 2 onwards.
- Gross pathology:
- Necropsy revealed no compound-related findings after 2000 mg/kg bw.
- Conclusions:
- A single oral administration (gavage) of the test substance to male and female rats at the limit-dose 2000 mg/kg bw was tolerated without mortalities, effects on body weight gain and gross pathological findings. Slight apathy in two females as well as slight sialorrhea in one female was seen on application day 1. All animals were without any clinical findings from day 2 onwards. According to OECD TG 423 the oral LD50 of ZK 50992 (epoxide valerate) in male and female rats is therefore > 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study conducted equivalent to OECD TG 423, groups Wistar rats, female and male (3/sex) were given a single oral dose of Epoxide-Valerate in 0.9 % NaCl + 0.085 % Myrj 53 in bidist. water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined => 2000 mg/kg bw
Limit test
No mortality occurred during the test
The administration of 2000 mg/kg bw provoked slight apathy in two females as well as slight diarrhea in one female on application day 1. All animals were without any clinical findings from day 2 onwards. There were no necropsy findings or changes in body weight.
The test item is of low Toxicity based on the LD50 in male and female Wistar rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is of good quality (Klimisch score = 1)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June to July 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- 3 instead of 5 animals/sex used
- GLP compliance:
- yes
- Remarks:
- - but a QA check was not performed
- 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: Schering AG
- Weight at study initiation: males: 105-111 g; females: 93-107 g
- Fasting period before study: ca. 19 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): pell. Altromin® R ad libitum
- Water (e.g. ad libitum): demineralized acidified water, pH 2-3 ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 54-64
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- other: 900 mg NaCl ad 100 ml bidest water
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- 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: Body weight on day 1, 7, and 14. General Observations were made daily.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died after administration of 2000 mg/kg bw.
- Clinical signs:
- other: A single dermal application of 2000 mg/kg was tolerated without compound-related findings.
- Gross pathology:
- Necropsy revealed no compound-related findings after 2000 mg/kg bw.
- Conclusions:
- A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test item in male and female rats is therefore > 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study according to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to Epoxide-Valerate in physiological saline for 24 hours at a dose 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
No mortality occurred during the limit test.
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is of good quality (Klimisch score = 1)
Additional information
In an acute oral toxicity study conducted equivalent to OECD TG 423, groups Wistar rats, female and male (3/sex) were given a single oral dose of Epoxide-Valerate in 0.9 % NaCl + 0.085 % Myrj 53 in bidist. water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined => 2000 mg/kg bw
Limit test
No mortality occurred during the test
The administration of 2000 mg/kg bw provoked slight apathy in two females as well as slight diarrhea in one female on application day 1. All animals were without any clinical findings from day 2 onwards. There were no necropsy findings or changes in body weight.
The test item is of low Toxicity based on the LD50 in male and female Wistar rats.
In an acute dermal toxicity study according to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to Epoxide-Valerate in physiological saline for 24 hours at a dose 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
No mortality occurred during the limit test.
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.
Justification for classification or non-classification
Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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