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Description of key information

LD50(oral): > 2000 mg/kg bw (Mitsui Chem Inc. 2000)

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan U.K. Ltd, Bicester, Oxon, England
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: 93 - 105 g
- Housing: in groups of 5 rats per cage
- Diet (e.g. ad libitum): ad libitum (Special Diet Services RM1(E) SQC expanded pellet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 22.5 °C
- Humidity (%): 41 - 63 %
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One female died within four hours of dosing. Macroscopic examination of this animal revealed congestion (characterised by darkened tissues/organs, prominent blood vessels or enlarged, swollen or thichended tissues) in the subcutaneous tissue, brain and heart. Congestion and fluid contents were also noted in the stomach and along the alimentary tract.
Clinical signs:
Piloerection was observed in all rats soon after dosing. This sign persisted and was accompanied in all animals by salivation, abnormal gait and hunched posture. In addition, lethargy, reduced body temperature, thin appearance, ungroomed appearance, prostration, reduced body tone, noisy respiration, shallow respiration, pallor to the skin, swollen abdomen and partially closed eyelids were seen in one or more animals during the study. Piloerection. thin appearance, hunched posture, noisy respiration, pallor to the skin and swollen abdomen were still evident in one or more animals at study termination an Day 15.
Recovery of remaining animals surviving treatment, as judged by external appearance and behaviour, was complete by Day 10.
Body weight:
A slight bodyweight loss was recorded for one male and one female on Day 8. All other animals were considered to habe achieved satisfactory bodyweiht gaints throughout the study.
Gross pathology:
Macroscopic examination of the surviving animals killed at study termination (Day 15) revealed adhesion of the liver to the thoracic/abdominal wall with atrophy of the kidneys and stomach. Congestion (characterised by prominent blood vessels and enlarged, swollen or thickened tissues) was also noted in the stomach and along the alimentary tract.

Mortality date (main study)

Sex

No of deaths in group of 5

Day*

1

2 to 14

1h

2h

3h

4h

a         b

Male

 

 

 

 

 

 

Female

 

 

 

 

1

 

a First observation

b Second observation

 * The day/hour indicated is the time that the animals was observed to die or found dead

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute toxicity of FAM was tested in an OECD Guideline 401(acute oral toxicity) test in rats. One female died within four hours of dosing. Piloerection was observed in all rats soon after dosing. This sign persisted and was accompanied in all animals by salivation, abnormal gait and hunched posture. In addition, lethargy, reduced body temperature, thin appearance, ungroomed appearance, prostration, reduced body tone, noisy respiration, shallow respiration, pallor to the skin, swollen abdomen and partially closed eyelids were seen in one or more animals during the study. A slight bodyweight loss was recorded for one male and one female on Day 8. Macroscopic examination of the surviving animals killed at study termination (Day 15) revealed adhesion of the liver to the thoracic/abdominal wall with atrophy of the kidneys and stomach. The LD50 was greater 2000 mg/kg bw [Mitsui Chem Inc. 2000]


Justification for selection of acute toxicity – oral endpoint
only one study available
effect level: LD50 > 2000 mg/kg bw

Justification for classification or non-classification

Based on the results obtained in the acute oral toxicity study (LD50 > 2000 mg/kg bw) the test item does not need to be classified according to 67/548/EEC (DSD) and to Regulation (EC) No 1272/2008 (GHS).