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Administrative data

Description of key information

Oral administration of the test material to rats at the extreme dose of 15000 mg/kg bw resulted

in only 1 death. Animals showed only transient adverse effects.

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, no GLP, short report, no analytical data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre.dates GLP-regulations
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Diet (e.g. ad libitum): starved overnight before treatment

no further data
Route of administration:
oral: gavage
Vehicle:
other: water with 0,5 % tragacanth
Details on oral exposure:
VEHICLE
- Aqueous tragacanth (0,5 %)
- Concentration in vehicle: 40 %


MAXIMUM DOSE VOLUME APPLIED: 37,5 mL/kg
Doses:
15000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
One female rat died within 66 hours after treatment.
Clinical signs:
Lethargy, piloerection, and diarrhoea. Orange stained urine was observed from all rats.
Body weight:
Body weight gain was decreasedin treated rats of both sexes in week one after treatment.
Gross pathology:
Normal
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The extreme limit dose of 15000 mg/kg aplied by oral gavage to rats caused death in 1 of 10 animals only. The LD50 was above 15000 mg/kg bw..
Executive summary:

METHOD:

10 rats (five males and five females) of the CFY strain, in the weight range 130 to 158 g were starved overnight before treatment with the test item.
The test item was prepared as a 40% suspension in aqueous gum tragacanth (0. 5%) and administered by oral intubation at a dosage volume of 37.5 ml/kg bodyweight. Rats treated with the vehicle alone (37.5 ml/kg) served as controls. During the observation period of 14 days, a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in an attempt to identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage.

RESULTS

Ten rats were treated with the test item at a dosage level of 15 g/kg bodyweight.

Signs of reaction to treatment, observed shortly after dosing, consisted of lethargy, piloerection and diarrhoea. Orange stained urine was observed from all rats.

One female rat died within 66 hours of treatment. Autopsy did not reveal any specific cause of death. Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within two days of treatment. Slightly depressed bodyweight gains were observed during the first week of observation, but returned to normal during the second week of observation, compared with controls. Terminal autopsy findings were normal.

 

CONCLUSION

The acute median lethal oral dose (LD50) to rats of the test item was found to be greater than 15000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw
Quality of whole database:
Early study before GLP regulation, but delivering essential information for safety assessment.

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

Even the extreme oral dose of 15000 mg/kg bw caused only trasient slight effects in survivors. One of ten animals died. The LD50 was clearly above 15000 mg/kg bw and a classification is not warranted.


Justification for selection of acute toxicity – oral endpoint
only available study

Justification for classification or non-classification

The LD50 was above 15000 mg/kg bw. Classification is not warranted.