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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

Referenceopen allclose all

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:
No clinical-toxicological symptoms observed
Body weight:
Body weight changes after the observation period showed a normal weight gain
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:
No clinical-toxicological symptoms observed
Body weight:
Body weight changes after the observation period showed a normal weight gain
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)
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