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Description of key information

The median lethal dose of FAT 60'253/A after single oral administration and via dermal route to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight

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
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
other: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation:Males:8 -10 weeks
Females: 8 -10 weeks
- Weight at study initiation:Males: 239.7 - 249.7 g
Females: 175.5-188.3 g
- Housing:Groups of three in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet (e.g. ad libitum):Pelleted standard Kliba 3433, batch no. 03/00, rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum (except during treatment, see section 5.6). Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period:One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-23.5
- Humidity (%):39-61
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12- hour artificial fluorescent light, 12-hour dark cycle.
Route of administration:
oral: gavage
Vehicle:
other: Polyethyleneglycol PEG 300
Details on oral exposure:
VEHICLE
- Concentration in vehicle:10 ml

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males
3 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,mortality
Statistics:
No statistical analysis was used.
Preliminary study:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
MORTALITY:
No deaths occurred during the test.
CLINICAL SIGNS:
No clinical signs of toxicity observed.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
Effects on organs:
No treatment-related macroscopic findings were observed.
Other findings:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of FAT 60'253/A after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight
Executive summary:

Two groups, each using three male or three female Hanlbm: WIST (SPF) rats, were treated with FAT 60'253/A at 2000 mg/kg by oral gavage. The test item was suspended in vehicle polyethylene glycol 300 (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15.

Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the observation period.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

The median lethal dose of FAT 60'253/A after single oral administration to rats of both sexes, observed over a period of 14 days is:

LD50 (rat): greater than 2000 mg/kg body weight

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

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
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
other: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation:Males: 8-10 weeks; Females: 10-12 weeks
- Weight at study initiation:Males: 255.9 - 273.3 g; Females: 189.8 - 205.4 g
- Housing:During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum):Pelleted standard Kliba 3433, batch no.03/00 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period:One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-23.5
- Humidity (%):39-57
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12-hour artificial fluorescent light, 12-hour dark cycle.
Type of coverage:
semiocclusive
Vehicle:
other: Polyethylene glycol 300 (PEG 300)
Details on dermal exposure:
TEST SITE
- % coverage: 10%
- Type of wrap if used:The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the skin reaction of the application sites were assessed.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,mortality
Statistics:
The toxicity was estimated without the use of a statistical method.
Preliminary study:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
No systemic or local signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of FAT 60'253/A after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight
Executive summary:

A group of five male and five female Hanlbm: WIST (SPF) rats was treated with FAT 60'253/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (polyethylene glycol, PEG 300) at a concentration of 0.4 g/ml and administered at a volume of 5 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the observation period.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

The median lethal dose of FAT 60'253/A after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
GLP guideline study

Additional information

In an acute oral toxicity key study, two groups, each using three male or three female Hanlbm: WIST (SPF) rats, were treated with FAT 60'253/A at 2000 mg/kg by oral gavage. The test item was suspended in vehicle polyethylene glycol 300 (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15.

Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the observation period.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

The median lethal dose of FAT 60'253/A after single oral administration to rats of both sexes, observed over a period of 14 days is:

LD50 (rat): greater than 2000 mg/kg body weight

In an acute dermal key study, a group of five male and five female Hanlbm: WIST (SPF) rats was treated with FAT 60'253/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (polyethylene glycol, PEG 300) at a concentration of 0.4 g/ml and administered at a volume of 5 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the observation period.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

The median lethal dose of FAT 60'253/A after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight

Justification for classification or non-classification

The median lethal dose of FAT 60'253/A after single oral administration and via dermal route to rats of both sexes, observed over a period of 14 days is:

LD50 (rat): greater than 2000 mg/kg body weight