Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26th Sep 1991 - 10th Oct 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation Document is incomplete, but basic data can be derived.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
, document is incomplete, but basic data can be derived.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pielik 85 SP; 2,4-D sodium salt
- Physical state: white powder with intense smell
- Analytical purity: 94%
- Impurities (identity and concentrations): Chlorphenols expressed as 2,4-D Chlorphenol (0.3%); Substances insoluble in water (0.01%)
- Purity test date: 11th July 1991 (Certificate No. 1046/PK 91)
- Melting temperature of the 2,4-D acid: 139°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Medical School, Department of Toxicology, Poznan
- Age at study initiation: 2.5 months (mean)
- Weight at study initiation: 279 g for males (mean), 216 g for females (mean)
- Housing: plastic metal cage (35 x 30 x 20 cm3), 5 animals of the same sex per cage
- Diet: "Murigran" ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 40 - 80%
- Photoperiod (hrs dark / hrs light): 12 hour light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
not reported
Doses:
364, 473, 615 and 800 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
552 mg/kg bw
Based on:
test mat.
Mortality:
Three male and one female animal of the highest dose group died on day 1 after application, the other animals of this dose group died on day two, respectively. In the group receiving 615 mg/kg bw, three male and one female animal died on day 3, treatment with 473 mg/kg bw led to the death of one female rat on day 3 and to the death of one male and one female rat on day 4.
Clinical signs:
The animals in the highest dose group were dejected and less active, starting shortly after the application of the test substance until death. Their hair was bristled. In the lower dose groups no toxic signs were observed except for animals that died. Shortly before death they were less mobile and had bristled hair.
Body weight:
Some rats in all groups showed a lower increase of body weight.
Gross pathology:
Hyperemia was found in the internal organs of the rats that died during the observation period. In addition, in 2 rats at 615 mg/kg bw softening in the liver was noticed. In the surviving rats megalosplenia was observed.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU