Registration Dossier

Administrative data

Description of key information

LD50 (rat, oral) is greater than 2000 mg/kg bw.
LD50 (rat, dermal) is greater than 2000 mg/kg bw.

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:
from N0V. 14 to DEC.19, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance test with GLP compliance
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: Directive 92/69/EEC, B.l. "Acute Toxicity-Oral", July 31, 1992.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Test System: Rat, HanIbm:WIST (SPF)
Number of animals per group: 5 males and 5 females
Age when treated: males: 8 weeks, females: 10 weeks
Body weight range when treated: males: 197.1 - 218.5 g, females: 174.8 - 186.3 g
Acclimatization: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Conditions:
Standard Laboratory Conditions.
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with target ranges for temperature of 22 ± 3 degrees centigrade, and for relative humidity between 40-70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bi-distilled water
Details on oral exposure:
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 17 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
Doses:
2000 mg/kg body weight (10 mL/kg body weight)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The test item was administration to a group of 5 male and 5 female rats by oral gavage, at the single dose of 2000 mg/kg body weight. The application volume was 10 mL/kg body weight. The animals were examined and mortality, viability and clinical signs were recorded. All surviving animals were necropsied and examined macroscopically after the end of the observation period.
Statistics:
The LOGIT-Model could not be used as no deaths occurred.
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 clinical signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the range of physiological variability known for rats of this strain and age, except one female animal (no. 8) showed a slight loss of body weight during the second observation period.
Gross pathology:
No macroscopic findings were observed at necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (rat, oral) of the test substance is greater than 2000 mg/kg body weight.
Executive summary:

A group of five male and five female HanIbm:WIST (SPF) rats was treated with FAT 45'176/A at 2000 mg/kg body weight by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg body weight. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age, except one female animal (no. 8) showed a slight loss of body weight during the second observation period. No macroscopic findings were observed at necropsy.

The LD50(rat, oral) is greater than 2000 mg/kg body weight. And the test substance is not be classified according to the CLP regulation (Regulation EC No. 1272/2008).

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:
Nov. 26, 1996 - Jan. 10, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guidance test with GLP compliance
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Test System: Rat, HanIbm:WIST (SPF)
Number of animals per group: 5 males and 5 females
Age at treatment: 8 weeks (males) and 11 weeks (females)
Initial Body Weight at Start of Treatment: males: 233.5 -258.7 g and females: 201.8-224.9 g.

Conditions
Standard Laboratory Conditions.
Air-conditioned with ranges for room temperature of 22 ± 3 °C and relative humidity 40-70 % and approximately 10-15 air changes per hour. 12 hours artificial fluorescent light /12 hours dark, music during the light period.
Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
bi-distilled water
Details on dermal exposure:
One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. Only those animals without injury or irritation on the skin were used in the test.
On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 4 mL/kg
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.
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight (4 mL/kg)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
no data
Statistics:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
No systemic signs of toxicity were observed.
Body weight:
no significant change
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
no data
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of test item after single dermal administration to rats of both sexes was observed over a period of 14 days.
The LD50 (rat, dermal) is above 2000 mg/kg body weight.
Executive summary:

The test item was administrated to a group of 5 male and 5 female rats by dermal application, at the single dose of 2000 mg/kg body weight.

No death occurred during the study period. No clinical signs of systemic toxicity were observed during the observation period. There were no test item-related effects on body weight of the male and females animals during the observation period. No organ abnormalities were observed at necropsy.

The LD50 of test item was estimated to be greater than 2000 mg/kg.bw and the test substance is consequently not classified according to the CLP regulation (Regulation EC No. 1272/2008) for acute dermal toxicity.

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

Additional information

Oral toxicity test and dermal toxicity test of the test substance were performed under GLP test condition according to the OECD guideline. The inhalation toxicity test is waived according to COLUMN 2 of REACH ANNEX VIII.

The test item was administrated to a group of 5 male and 5 female rats by oral gavage, at the single dose of 2000 mg/kg body weight.

No clinical signs of toxicity were observed during the observation period.There was no effect on body weight gain during the observation period.No organ abnormalities were observed at necropsy. Thus, LD50(rat, oral) is greater than 2000 mg/kg body weight.

The test item was administrated to a group of 5 male and 5 female rats by dermal application, at the single dose of 2000 mg/kg body weight. No death occurred during the study period. No clinical signs of systemic toxicity were observed during the observation period.

There were no test item-related effects on body weight of the male and females animals during the observation period. No organ abnormalities were observed at necropsy. Therefore, the LD50 of test item was estimated to be greater than 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
OECD guidance test with GLP compliance

Justification for selection of acute toxicity – dermal endpoint
OECD guidance test with GLP compliance

Justification for classification or non-classification

Based on the acute oral and dermal toxicity test results, the test substance is not classified according to the CLP regulation (Regulation EC No. 1272/2008). Based on available data also no classification for STOT SE is required and given that the substance is solid classification for aspiration hazards is als not applicable according to CLP.