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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

oral
rat: LD50 > 2200 mg/kg bw, no mortalities (GLP, OECD 401, BASF 1991)
dermal
rat: LD50 > 2000 mg/kg bw, no mortalities (GLP, OECD 402, BASF 1991)

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
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: Dr. K. Thomae GmbH, Biberach, D
- Age at study initiation: Young adult animals
- Weight at study initiation: 187 (m); 179 (f); no more than +/-10% of the mean weight
- Fasting period before study: at least 16 h
- Housing: single in stainless steel wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, CH; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 44 g/100 mL
- Justification for choice of vehicle: Poor solubility of the test substance in aqua dest.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Doses:
2200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation period was 14 days. Body weight determination: Individual body weights shortly before application, weekly thereafter and at the end of the study. Recording of signs and symptoms several times on the day of administration, at least once each working day for the individual animals.
A check for general observations and mortality was made twice each working day and once on saturdays, sundays and public holidays. Necropsy was done at the last day of the observation period. Withdrawal of food at least 6 h before deaths with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible.
Statistics:
-
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Mortality:
No mortality
Clinical signs:
other: Male animals: dyspnoe, staggering, piloerection, impaired general state and additionally in one male animal apathy and poor general state. The male animals were normal at about 1 - 6 days after application. Female animals: piloerection on the day of appli
Gross pathology:
No abnormalities observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance does not show significant acute toxicity. Therefore a classification is not warranted according to 67/548/EEC or UN-GHS.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 200 mg/kg bw

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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: Dr. K. Thomae GmbH, Biberach, D
- Age at study initiation: Young adult animals
- Weight at study initiation: 200 - 300 g; +-20% of the mean weight
- Housing: single in stainless steel wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, CH; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Single application of 2.2 ml/kg bw (density 0.908 g/mL) to the clipped epidermis (dorsal and dorsolateral parts of the trunk); covering of the application site with a semiocclusive dressing for 24 hours, afterwards removal of the dressing. Rinsing of the application site with warm water.
Clipping of the fur: at least 15 hours before the beginning of the study.
Duration of exposure:
single application for 24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
Observation period: 14 days
Body weight determination: Individual body weights shortly before application, weekly thereafter and at the end of the study period.
Signs and symptoms: Recording several times on the day of administration, at least once each working day for the individual animals.
Scoring of skin findings: Individual readings 30 - 60 min after removal of the semiocclusive dressing, weekly thereafter and at the and of the study period.
General observations and mortality: A check was made each working day and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
Pathology: Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before death with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible.
Statistics:
-
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities observed.
Clinical signs:
other: No abnormalities observed.
Gross pathology:
No pathologic findings noted.
Other findings:
No local abnormalities observed.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral

In an acute oral toxicity limit test following GLP requirements and according to OECD test guideline 401, groups of five fasted, young adult Wistar rats per sex were given a single oral dose of Keroflux ES 3241 (purity not reported) in olive oil at a dose of 2200 mg/kg bw in 5mL/kg bw and observed for 14 days (BASF AG 1991). No mortalities, irregular body weight changes or necropsy findings were observed. Dyspnoe, staggering, piloerection, impaired general state and apathy were the observed reversible clinical signs.The oral LD50 is therefore considered to be >2200 mg/kg bw.

Dermal

In an acute dermal limit test following GLP requirements and according to OECD test guideline 402, groups of five young adult Wistar rats per sex were dermally exposed to Keroflux ES 4132 (unchanged; purity not reported) for 24 h under semiocclusive conditions at a dose of 2000 mg/kg bw. Animals then were observed for 14 days. No mortalities, irregular body weight changes, clinical signs, local effects or necropsy findings were observed. The dermal LD50 is therefore considered to be >2000 mg/kg bw.

Inhalation

No route of exposure

Justification for classification or non-classification

No classification for acute oral or dermal toxicity according to 67/548/EEC and 1272/2008/EEC, respectively, is warranted since no specific signs of toxicity were observed at doses of 2200 or 2000 mg/kg bw.