Registration Dossier
Registration Dossier
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EC number: 810-472-7 | CAS number: 159325-45-8
Toxicological information
Endpoint summary
Administrative data
Description of key information
The oral LD50 and dermal LD50 in rats is considered to be >2,000 mg/kg bw.
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:
- 28 October 1997 - 13 November 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to international guideline and GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- 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: Charles River, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Housing: Group housing (polycarbonate cages) 3 animals per sex
- Diet (e.g. ad libitum): Free access, standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhour, Belgium).
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 October 1997 To: 13 November 1997 - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
- Doses:
- 2000 mg/kg (10 ml/kg) body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability - Twice daily; Body Weight - Days 1 (pre-administration), 8 and 15; Clinical Signs - periodic intervals on day of dosing, and once daily thereafter, until day 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Necropsy was performed at the end of the observation period and internal macroscopic abnormalities were recorded. - Statistics:
- None performed
- Preliminary study:
- Since the 2000 mg/kg limit test resulted in no adverse effects, or mortalities in the study group, no additional dose levels were required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: There were no signs toxicity throughout the 15 day observation period. All male and females animals appeared normal throughout the observation period.
- Gross pathology:
- No abnormalities were observed at the macroscopic level for all animals necropsied at the conclusion of the 15-day observation period.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, when administered as supplied to 3 male and 3 female Wistar rats, indicates an acute oral LD50 greater than 2000 mg/kg.
- Executive summary:
The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 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
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 October 1997 - 13 November 1997
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- 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: Charles River, sulzfed, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: Males (average): 369 grams; Females (average) 235 grams
- Fasting period before study: No
- Housing: Individually in polycarbonated cages
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (Carfil Quality BVBA, OUd-Turnhout, Belgium).
- Water (e.g. ad libitum): Free access tap-water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10% of total body surface
- Type of wrap if used: Gauze patch, fixed successively to aluminium foil and Coban elastic bandage; in addition micropore tape was used.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap-water moistened tissue
- Time after start of exposure: 24 hours after application - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males;
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability - Twice Daily; Body Weights - Day 1 (pre-administration), day 8 and day 15; Clinical Signs - periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Internal macroscopic abnormalities - Preliminary study:
- Since the 2000 mg/kg body weight limit test resulted in no adverse effects, or mortalities in the study group, no additional dose levels were required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality reported.
- Clinical signs:
- other: General or focal erythema, scales and scabs on the back or flank were reported in one male and two females. By day 8 the females recovered from symptoms, however scabs persisted in the male at termination of study. Yellow staining of the skin by the test
- Gross pathology:
- No treatment related abnormalities were reported at the macroscopic level.
Pelvic dilation of the kidneys were found in one male, however this is a common occurrence among rats of this age and strain and was not considered toxicologically related. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance, when administered as supplied to 5 male and female Wistar rats, appears to have an acute dermal LD50 greater than 2000 mg/kg
- Executive summary:
The dermal LD50 value of the test substance in rats was established as exceeding 2000 mg/kg body weight.
Reference
| Clinical Signs - Males | |||||||||||||||||||
| Test day | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||
| Time after treatment Hours | 0 | 2 | 4 | ||||||||||||||||
| Animal No. | Signs | Max Grade | |||||||||||||||||
| 1 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 2 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
| 3 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 4 | Skin/Fur/Plumage/Erythema Focal (Back) | 4 | - | - | - | 2 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - |
| Scabs (Back) | 3 | - | - | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
| Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
| 5 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| Clinical Signs - Females | |||||||||||||||||||
| Test day | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||
| Time after treatment Hours | 0 | 2 | 4 | ||||||||||||||||
| Animal No. | Signs | Max Grade | |||||||||||||||||
| 6 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 7 | Skin/Fur/Plumage/General Erythema (Back) | 4 | - | - | - | 2 | 2 | 2 | 1 | 1 | 1 | - | - | - | - | - | - | - | - |
| Scales (Back) | 3 | - | - | - | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | |
| Skin Yellow (Flank Left) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
| 8 | Skin/Fur/Plumage/General Erythema (Back) | 4 | - | - | - | 2 | 2 | 2 | - | - | - | - | - | - | - | - | - | - | - |
| Erythemal Focal (Flank Right) | 4 | - | - | - | - | - | - | 2 | 2 | 1 | - | - | - | - | - | - | - | - | |
| Scales (Back) | 3 | - | - | - | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | |
| Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | |
| Skin Yellow (Flank Left) | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | 1 | 1 | 1 | 1 | |
| 9 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| 10 | Skin/Fur/Plumage/Skin Yellow (Back) | 1 | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- mg/kg bw
Additional information
The oral LD50 and dermal LD50 in rats is considered to be >2,000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg body weight.
Justification for selection of acute toxicity – dermal endpoint
The dermal LD50 value of the test substance in rats was established as exceeding 2000 mg/kg body weight.
Justification for classification or non-classification
Epyrron is classified as not hazardous according to the Directive 67/548 EEC and Regulation (EC) 1272/2008 (CLP).
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