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Administrative data

Description of key information

In rats, the LD50 after oral administration was 2100 mg/kg body weight.

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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: SD derived
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Geigy UK
- Age at study initiation: 5 weeks
- Weight at study initiation: 110g (females), 108g (males)
- Fasting period before study: 18 h
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70+/-5
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg
Doses:
500, 1000, 1500, 2000, 2500, 3000 mg/kg
No. of animals per sex per dose:
5
Statistics:
From the mortality data recorded the LD50 value and its 95% confidence limits were calculated by the method of Litchfield, J.T and Wilcoxon, F. W., 1949, 3. Pharmac. Exp. Ther., 96, 99.
Preliminary study:
In order to determine approximate dose levels for the main study, a range-finding study was carried out using groups of two rats (1 of each sex). The results obtained suggested that the LD50 would be approximately 2000mg/kg.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 100 mg/kg bw
Based on:
test mat.
95% CL:
> 1 787 - < 2 468
Mortality:
yes, see table below
Clinical signs:
other: Lethargy was observed starting at the lowest dose levels. In addition, lacrimation (at 1500 and 2000 mg/kg) and piloerection (at 2000 mg/kg) was observed in some animals.
Gross pathology:
No Abnormalities detected

MORTALITIES

mortality
Dose (mg/kg bw) males females combined deaths %
500 0/5 0/5 0/10 0
1000 0/5 0/5 0/10 0
1500 0/5 1/5 1/10 10
2000 1/5 3/5 4/10 40
2500 4/5 5/5 9/10 90
3000 4/5 4/5 8/10 80
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 100 mg/kg bw

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

Oral acute toxicity

Groups of male and female rats were treated with the test article by gavage at dose levels of 500, 1000, 1500, 2000, 2500 and 3000 mg/kg. The study was performed prior to GLP and OECD guidelines but is reported with sufficient details. Observations were carried out for 14 days at which time the surviving rats were killed and autopsied. The animals showed lethargy, lacrimation and piloerection. No changes were reported during autopsy. Mortalities occurred at 1500 mg/kg and higher. From the mortalities the LD50 was calculated to be 2100 mg/kg bodyweight for both males and females.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.