Registration Dossier
Registration Dossier
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EC number: 272-038-8 | CAS number: 68649-95-6
Toxicological information
Endpoint summary
Administrative data
Description of key information
Acute toxicity (oral): the results of the 2 studies (OECD 401) are >4790 and >4986 mg/kg. The lowest is assigned as key value for the CSA.
Acute toxicity (dermal): the result of the study is >2000 mg/kg (OECD 402)
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:
- February 15, 1988 - March 3, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP, but well described and in accordance with OECD 401.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- 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: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld, Germany
- Age at study initiation: no data, but based on the animal weight at study start the animals were young adults
- Weight at study initiation:
male: 185.2 - 189.1 g
female: 150 - 167.7 g
- Fasting period before study: from 16 hours before treatment until 4 hours after treatment
- Housing: collective caging, Macrolon type III cages, with bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 ºC
- Humidity (%): 50 - 80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light, fluorescent light, 120 lux
IN-LIFE DATES: From: February 15, 1988 To: March 3, 1988 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE; none (administered as received)
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
DOSAGE PREPARATION (if unusual): administered as received
CLASS METHOD (if applicable): not relevant - Doses:
- 5 ml/kg bw (for pre-test and for main test)
- No. of animals per sex per dose:
- Pre-test: 2 females
Main test: 5 males and 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and symptoms about 20 min, 1 h, 2 h, 3 h, 6 h after treatment and once daily thereafter until day 14; weighing on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- not relevant
- Preliminary study:
- two female rats were administered 5 mL/kg bw; no mortality occurred
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 790 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: >5 mL/kg bw was equivalent to >4790 mg/kg bw
- Mortality:
- No mortalities
- Clinical signs:
- other: No clinical-toxicological symptoms observed
- Gross pathology:
- No macroscopic findings in the cranial-, thoracic- and abdominal cavity
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- based on Annex I of 1272/2008/EC (CLP)
- Conclusions:
- LD50 oral (rat): > 4790 mg/kg (>5 ml/kg)
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 15, 1988 - March 3, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP, but well described and in accordance with OECD 401.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- 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: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld, Germany
- Age at study initiation: no data, but based on the animal weight at study start the animals were young adults
- Weight at study initiation:
male: 181.4 - 187.7 g
female: 158.4 - 165.3 g
- Fasting period before study: from 16 hours before treatment until 4 hours after treatment
- Housing: collective caging, Macrolon type III cages, with bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 ºC
- Humidity (%): 50 - 80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light, fluorescent light, 120 lux
IN-LIFE DATES: From: February 15, 1988 To: March 3, 1988 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE; none (administered as received)
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
DOSAGE PREPARATION (if unusual): administered as received
CLASS METHOD (if applicable): not relevant - Doses:
- 5 ml/kg bw (for pre-test and for main test)
- No. of animals per sex per dose:
- Pre-test: 2 females
Main test: 5 males and 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and symptoms about 20 min, 1 h, 2 h, 3 h, 6 h after treatment and once daily thereafter until day 14; weighing on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- not relevant
- Preliminary study:
- two female rats were administered 5 mL/kg bw; no mortality occurred
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 986 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: >5 mL/kg bw was equivalent to >4986 mg/kg bw
- Mortality:
- No mortalities
- Clinical signs:
- other: No clinical-toxicological symptoms observed
- Gross pathology:
- No macroscopic findings in the cranial-, thoracic- and abdominal cavity
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- based on Annex I of 1272/2008/EC (CLP)
- Conclusions:
- LD50 oral (rat): > 4986 mg/kg (>5 ml/kg)
Referenceopen allclose all
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 4 790 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
The substance does not need to be classified for acute toxicity as:
LD50 oral (rat): >4790 mg/kg
LD50 dermal (rat): >2000 mg/kg
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