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Administrative data

Description of key information

Based on the available acute oral and dermal studies the test material is not toxic, at a dose level of 2000 mg/kg of body weight.

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
None
Species:
rat
Strain:
other: TIf:RAI
Sex:
male/female
Details on test animals and environmental conditions:
The experiments were performed on healthy, young, random-bred rats of the Tif RAI strain. Their mean initial body weight was between 91 and 108 g. The animals had previously been acclimatized in our laboratories for at least 5 days to a constant room temperature of 22±1 °C, a relative humidity of 55±5% and 14 hours light/day. They were housed in groups of 5 in macrolon cages (Size 3). The animals were fed a standard diet of Nafag ad libitum and had free access of drinking water.

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
2%
Details on oral exposure:
Tgroups of 5 male and 5 female rats, after having been fasted overnight, were given various single doses of the compound, suspended in water by gavage.
Doses:
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Symptoms and mortality after administration were recorded during an observation period of 8 days.
Statistics:
Not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No symptoms were recorded.
Body weight:
No effect on body weight gain was seen.
Gross pathology:
Not specified

None

Interpretation of results:
GHS criteria not met
Conclusions:
The athe acute oral median lethal dose (LD50) of compound FAT 65004/B to rats is greater than 15000 mg/kg body weight.
Executive summary:

The acute oral toxicity potential of the test substance was evaluated in a study conducted with Tif:RAI strain rats. Groups of 5 male and 5 female rats, after having been fasted overnight, were given various single doses of the compound, suspended in water by gavage. The doses administered were 1000, 3000, 10000 and 15000 mg/kg bw. No symptoms were recorded and no deaths occurred. Hence, it was concluded that the acute oral median lethal dose (LD50) of compound FAT 65004/B to rats is greater than 15000 mg/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
None
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
None
Species:
rat
Strain:
other: TIf:RAI
Sex:
male/female
Details on test animals and environmental conditions:
The experiments were performed on healthy, young, random-bred rats of the Tif RAI strain purchased from the breeder. Their mean initial body weight was between 90 and 115 g. The animals had previously been acclimatized in our laboratories for at least 5 days to a constant room temperature of 22±1 degree C, a relative humidity of 55±5% and 14 hours light/day. They were housed in groups of 5 in macrolon cages (Size 3). The animals were fed a standard diet of Nafag ad libitum and had free access of drinking water.

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
Tgroups of 5 male and 5 female rats, after having been fasted overnight, were given various single doses of the compound, suspended in carboxymethylcellulose 2% (CMC) by gavage.
Doses:
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Symptoms and mortality after administration were recorded during an observation period of 8 days.
Statistics:
Not specified
Mortality:
No deaths occurred.
Clinical signs:
No symptoms were recorded.
Body weight:
No effect on body weight gain was seen.
Gross pathology:
Not specified

None

Interpretation of results:
GHS criteria not met
Conclusions:
The athe acute oral median lethal dose (LD50) of compound FAT 65004/A to rats is greater than 15000 mg/kg body weight.
Executive summary:

The acute oral toxicity potential of the test substance was evaluated in a study conducted with Tif:RAI strain rats. Groups of 5 male and 5 female rats, after having been fasted overnight, were given various single doses of the compound, suspended in carboxymethylcellulose 2% (CMC) by gavage. The doses administered were 1000, 3000, 10000 and 15000 mg/kg bw. No symptoms were recorded and no deaths occurred. Hence, it was concluded that the acute oral median lethal dose (LD50) of compound FAT 65004/A to rats is greater than 15000 mg/kg body weight.

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
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Sample label: DCT-90162
Description: White liquid
Specific gravity: 0.98
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
New Zealand White rabbits, at least 8 weeks old when received, were equilibrated for at least one week in this laboratory. Two male and two female apparently healthy rabbits, were selected for the test.
The animals were housed 1/cage in suspended wire mesh cages (30" x 18" x 18"). Fresh Purina rabbit chow and water were freely available. The animal room, reserved exclusively for rabbits on acute tests, was maintained at 20 - 21°C and was kept clean in accordance with the standards of AAALAC.

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Site Preparation -
24 hours prior to dosing, the fur was clipped from thebacks of the animals. The clipped area was 200 square cm, approximately 10 % of the body surface. Just prior to dosing, abrasions were made in one half of the rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding.

Observations -
Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system (attached). The rabbits were observed dail y for 14 days for signs of toxicity , pharmacological effects and mortality . Body weights were recorded pretest and i n the survivors at 7 and 14 days.

Termination -
At 14 days, the survivors were sacrificed . All animals were examined fo r gross pathology.

Duration of exposure:
24 hrs
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 male and 2 female
Control animals:
no
Details on study design:
Treatment -
Two male and two female rabbits were dosed at 2.0 g/kg. For liquid materials the dose was based on the sample weight as calculated from the specific gravity. The test material was applied once dermally to the prepared site under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material. The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. An estimate of the amount of material remaining was recorded. The exposure site was washed with warm tap water to remove excess material.
Statistics:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
All animals were normal except for animal #4288-F which had diarrhea on Days 1 and 4 and lethargy an Days 1 and 2
Body weight:
No effect
Gross pathology:
All animals, sacrifice d on Day 14, were normal

None

Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not toxic at a dose level of 2000 mg/kg of body weight.
Executive summary:

In a study conducted similar to OECD 434 guideline 2 male and 2 female New Zealand White rabbits were exposed to 2000 mg/kg of test substance FAT 65004.

Two male and two female rabbits were dosed at 2.0 g/kg. For liquid materials the dose was based on the sample weight as calculated from the specific gravity. The test material was applied once dermally to the prepared site under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material. The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. An estimate of the amount of material remaining was recorded. The exposure site was washed with warm tap water to remove excess material.

Observations -

Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system (attached). The rabbits were observed dail y for 14 days for signs of toxicity , pharmacological effects and mortality . Body weights were recorded pretest and i n the survivors at 7 and 14 days.

Termination -

At 14 days, the survivors were sacrificed . All animals were examined fo r gross pathology.

Results-

The 2 male and 2 females dosed at 2000 mg/kg survived in generally good health . There were no skin reactions, Body weights and necropsy findings were normal.

The test material is not toxic , at a dose level of 2000 mg/kg of body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

In 2 key studies the acute oral toxicity potential of the test substance was evaluated in a study conducted with Tif:RAI strain rats. Groups of 5 male and 5 female rats, after having been fasted overnight, and treated by gavage. The doses administered were 1000, 3000, 10000 and 15000 mg/kg bw. No symptoms were recorded and no deaths occurred. Hence, it was concluded that the acute oral median lethal dose (LD50) of compound FAT 65004/A to rats is greater than 15000 mg/kg body weight.

In another support study the acute oral toxicity potential of the test substance was evaluated in a limit test conducted with Sprague-Dawley rats. 5 males and 5 females received a single dose of 10 mL/kg bw by gavage. No symptoms were recorded and no deaths occured. Hence, it was concluded that the acute oral median lethal dose (LD50) of compound FAT 65 004 to rats is greater than 10 mL/kg body weight.

 

In an acute dermal toxicity study conducted similar to OECD 434 guideline 2 male and 2 female New Zealand White rabbits were exposed to 2000 mg/kg of test substance FAT 65004. Dermal reactions were scored at 25 hours, 7 and 14 days by the Draize scoring system (attached). The rabbits were observed dail y for 14 days for signs of toxicity , pharmacological effects and mortality . Body weights were recorded pretest and i n the survivors at 7 and 14 days. The 2 male and 2 females dosed at 2000 mg/kg survived in generally good health . There were no skin reactions, Body weights and necropsy findings were normal. The test material is not toxic , at a dose level of 2000 mg/kg of body weight.

Justification for classification or non-classification

Based on the available data from acute toxicity study with FAT 65004, the test substance does not meet the criteria for classification for acute toxicity according to the CLP (1272/2008) Regulation.