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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance is considered to have LD50 > 2000 mg/kg bw on acute oral as well as dermal administration.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
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:
Slightly ruffled fur was noted in all animals at the 2-hour reading and persisted in four out of six animals at the 3-hour reading. Hunched posture was also noted in two animals at the 2- and 3-hour reading.
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.

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 41048 is considered to have an oral LD50 >2000 mg/kg body weight.
Executive summary:

Currently no study to assess acute toxicity of FAT 41048 on oral exposure is available.

However, structural analogue FAT 41039/A was evaluated for acute oral toxicity in a study conducted according to OECD Guideline 401 and EU Method B.1. Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with FAT 41039/A by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle PEG 300) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during 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.

All animals survived until the end of the study period. Slightly ruffled fur was noted in all animals at the 2-hour reading and persisted in four out of six animals at the 3-hour reading. Hunched posture was also noted in two animals at the 2 - and 3-hour reading. Orange feces were noted in the cages of both groups on test day 2. The body weight of the animals was within the range commonly recorded for this strain andage. No macroscopic findings were recorded at necropsy. Hence, based on the findings of the study, the median lethal dose of FAT 41039/A after single oral administration to female rats, observed over a period of 14 days was >2000 mg/kg body weight.

Using the principles of read across, FAT 41048 is also considered to have an oral LD50 >2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
High quality GLP 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
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 were observed during the course of the study. Orange discoloration of the treated skin area produced by the test item prevent the assessment of a possible erythema in all animals on test day 2 and in one male animal on test day 3.
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.

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 41048 is also considered to have dermal LD50 >2000 mg/kg body weight.
Executive summary:

Currently no study to assess acute toxicity on dermal exposure of FAT 41048 is available. However, structural analogue, FAT 41039/A was evaluated for acute dermal toxicity in a study conducted according to OECD Guideline 402 and EU Method B.3. Five male and five female HanRcc.WIST (SPF) rats were treated with FAT 41039/A at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.33 g/mL and administered at a volume dosage of 6 mL/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1,2,3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during 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 or clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Hence, based on the findings of the study, the median lethal dose (LD50) of FAT 41039/A after single dermal administration to rats of both sexes, observed over a period of 14 days was >2000 mg/kg body weight.

Using the principles of read across, FAT 41048 is also considered to have dermal LD50 >2000 mg/kg body weight.

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

Additional information

Oral:

Currently no study to assess acute toxicity of FAT 41048 on oral exposure is available. However, structural analogue FAT 41039/A was evaluated for acute oral toxicity in a study conducted according to OECD Guideline 401 and EU Method B.1. Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with FAT 41039/A by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle PEG 300) at a concentration of 0.2 g/mL and administered at a volume dosage of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during 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.

All animals survived until the end of the study period. Slightly ruffled fur was noted in all animals at the 2-hour reading and persisted in four out of six animals at the 3-hour reading. Hunched posture was also noted in two animals at the 2 - and 3-hour reading. Orange feces were noted in the cages of both groups on test day 2. The body weight of the animals was within the range commonly recorded for this strain andage. No macroscopic findings were recorded at necropsy. Hence, based on the findings of the study, the median lethal dose of FAT 41039/A after single oral administration to female rats, observed over a period of 14 days was >2000 mg/kg body weight.

Using the principles of read across, FAT 41048 is also considered to have an oral LD50 >2000 mg/kg body weight.

Inhalation:

Currently no study to assess the acute inhalation toxicity potential of FAT 41048 is available. Poor water solubility and moderate partition coefficient values indicate that both chemicals may favour absorption across the respiratory tract epithelium by passive diffusion. However, owing to the high melting points (>300 °C), both chemicals can be considered to have low volatility and hence exposure through respiration is regarded to be low.Nevertheless, the use of this substance and the related products are not expected to result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Further, no systemic effects or mortality were observed in the acute oral and acute dermal toxicity studies with FAT 41039. Taking into consideration above information, acute inhalation exposure is considered to have negligible potential for systemic toxicity.

Dermal:

Currently no study to assess acute toxicity on dermal exposure of FAT 41048 is available. However, structural analogue, FAT 41039/A was evaluated for acute dermal toxicity in a study conducted according to OECD Guideline 402 and EU Method B.3. Five male and five female HanRcc.WIST (SPF) rats were treated with FAT 41039/A at 2000 mg/kg body weight by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.33 g/mL and administered at a volume dosage of 6 mL/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during 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 or clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Hence, based on the findings of the study, the median lethal dose (LD50) of FAT 41039/A after single dermal administration to rats of both sexes, observed over a period of 14 days was >2000 mg/kg body weight.

Using the principles of read across, FAT 41048 is also considered to have dermal LD50 >2000 mg/kg body weight.

Justification for classification or non-classification

The substance is considered to have LD50 >2000 mg/kg bw on acute oral as well as dermal administration, hence does not warrant classification according to Regulation (EC) No. 1272/2008 (CLP) criteria.