Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 1991 - Nov 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

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 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pielik 85 SP
- Physical state: dark brown solution with intense, characteristic 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: 11.07.1991 (Certificate No. 1046/PK 91)
- Melting temperature of the 2,4-D acid: 139°C

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Medical school, Department of Toxicology, Poznan, Poland
- Age at study initiation: 2,5 months (mean)
- Weight at study initiation: 220 g (mean)
- Housing: 5 animals per cage (35x 30x 20 cm)
- Diet: granulated standard food "Murigran" (Motycz, Poland), ad libitum
- Water: ad libitum (drinking water quality)


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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk (~4.5 x 6cm was clipped)

- Type of wrap if used: porous gauze dressuing fixed with non-irritating tape
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 (female only)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: every hour on day of treatment and subsequently twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight was evaluated on days 7 and 14.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occurred
Clinical signs:
No signs of systemic toxicity, no signs of dermal irritation
Body weight:
Body weight gain was normal except for one female animal which showed a body weight loss in the first week but recovered during the second week.
Gross pathology:
No abnormalities

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU