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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no fasting period before test material administration; no data on the analytical purity of the test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1987
Deviations:
yes
Remarks:
no fasting period before test material administration; no data on the analytical purity of the test substance
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-difluoroaniline
EC Number:
206-687-5
EC Name:
2,4-difluoroaniline
Cas Number:
367-25-9
Molecular formula:
C6H5F2N
IUPAC Name:
2,4-difluoroaniline

Test animals

Species:
rat
Strain:
other: CD (Sprague Dawley)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water (20%, v/v) containing Tween 80 (1%, v/v)
Doses:
0.4, 0.62, 1.0 and 1.6 mL/kg bw (corresponding to doses of 507, 786, 1268 and 2029 mg/kg bw based on a density of 1.268 g/mL obtained frome the literature (NTP, 1992))
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
0.75 mL/kg bw
Based on:
test mat.
95% CL:
> 0.6 - < 0.93
Remarks on result:
other: No mortalities occured at 0.4 mL/kg bw. 3/5 males rats died at 0.62 mL/kg bw and 5/5 males and 5/5 females died at 1.0 and 1.6 mL/kg bw.
Remarks:
The LD50 value is corresponding to a dose of 951 mg/kg bw based on a density of 1.268 g/mL.

Applicant's summary and conclusion

Interpretation of results:
other: acute oral toxicity observed
Conclusions:
In this acute oral toxicity test in rats, no mortalities occured at a dose of 0.4 mL/kg bw. 3/5 males rats died at a dose of 0.62 mL/kg bw, wheareas all females suvived at this dose level. 5/5 males and 5/5 females died at doses of 1.0 and 1.6 mL/kg bw. Clinical signs included tremors, sedation, dacryohaemorhoea, prostration, slight salivation, a loss of righting reflex, dirty fur and apparent hypothermia. Necropsy revealed no abnormalities at any dose level. The LD50 value was calculated to be 0.75 mL/kg bw (corresponding to a dose of 951 mg/kg bw based on a density of 1.268 g/mL). Based on the results and according to EU classification criteria, the test substance has to be classified.