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Administrative data

Description of key information

Acute oral toxicity (OECD TG 401): >5000 mg/kg bw.

Acute dermal toxicity (OECD TG 402): =5000 mg/kg bw.

Acute inhalation: no adverse effects predicted

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:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
No details.

ENVIRONMENTAL CONDITIONS
No details.
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No details.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No clinical signs were observed.
Body weight:
No data.
Gross pathology:
No data
Interpretation of results:
other: Not acute harmful.
Remarks:
According to Regulation (EC) No. 1272/2008.
Conclusions:
An LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats. Based on this result, the substance is not acute harmful.
Executive summary:

In an acute oral toxicity study performed equivalent to OECD 401 guideline, one group of 10 rats were orally exposed to the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No deaths occurred and no clinical signs were observed. An LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats. Based on this result, the substance is not acute harmful.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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:
Not reported.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no details on test material (purity not indicated), no details on test animals and environmental conditions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
No details.

ENVIRONMENTAL CONDITIONS
No details.
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No data.
Duration of exposure:
No data.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died on day 3 and two animals died on day 4.
Clinical signs:
The animals who died on day 3 and 4 showed ataxia at 24 hours followed by prostration and death. The surviving animals showed progressive drying and cracking, developing into shedding of skin and continuing up to end of the 14 days.
Body weight:
No data.
Gross pathology:
No data.
Interpretation of results:
other: Not acute harmful.
Remarks:
According to Regulation (EC) No. 1272/2008 and its mendments.
Conclusions:
An LD50 of 5000 mg/kg bw was obtained in the acute dermal toxicity study with rabbits. Based on the results, the substance is acutely toxic at 5000 mg/kg bw according to GHS.
Executive summary:

In an acute dermal toxicity study performed equivalent to OECD 402 guideline, one group of 6 rabbits were dermally exposed to 5000 mg/ kg bw of Fleuramone. The rabbits were observed for signs of toxicity and clinical signs for a period of 14 days. One animal died on day 3 and two animals died on day 4. The animals that died on day 3 and 4 showed ataxia at 24 hours followed by prostration and death. The surviving animals showed progressive drying and cracking, developing into shedding of skin and continuing up to end of the 14 days. Based on the results, an LD50 of 5000 mg/kg bw was obtained in the acute dermal toxicity study with rabbits. Based on the results, the substance is acutely toxic at 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute dermal toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed equivalent to OECD 401 guideline, one group of 10 rats were orally exposed to Fleuramone. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No deaths occurred and no clinical signs were observed. Based on the results, an LD50 of >5000 mg/kg bw was obtained in the acute oral toxicity study with rats. Based on this result, the substance is not acute harmful.

Acute inhalation:

Acute inhalation is predicted based on the acute oral toxicity in accordance with the CLP guidance document (2015, 3.1.3.3.4.page 255). The acute inhalation is predicted to be > 13000 mg/m3 and the saturated vapour pressure is 54 mg/m3. This means that the acute inhalation concentration cannot be reached and therefore no acute inhalation is anticipated.

Acute dermal toxicity:

In an acute dermal toxicity study performed equivalent to OECD 402 guideline, one group of 6 rabbits were dermally exposed to 5000 mg/ kg bw of Fleuramone. The rabbits were observed for signs of toxicity and clinical signs for a period of 14 days. One animal died on day 3 and two animals died on day 4. The animals that died on day 3 and 4 showed ataxia at 24 hours followed by prostration and death. The surviving animals showed progressive drying and cracking, developing into shedding of skin and continuing up to end of the 14 days. Based on the results, an LD50 of 5000 mg/kg bw was obtained in the acute dermal toxicity study with rabbits.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity by the oral, inhalation and dermal route according to Regulation (EC) No. 1272/2008 and its updates.

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