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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1984)
Deviations:
yes
Remarks:
, only minor reporting deficiencies, which do not affect the validity of the study
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diuron technical
- Purity test date: 98.8%
- Lot/batch No.: 232114080

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 160 - 200 g
- Housing: conventional Makrolon cages, 5 animals per cage
- Diet (e.g. ad libitum): "Altromin diet for rats and mice"
- Water: ad libitum
- Acclimation period: at least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: occusive dressing (method is according to Noakes and Sanderson (1969)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and soap
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
2500 and 5000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died during the observation period.
Clinical signs:
Application of 2500 mg/kg body weight was tolerated without any sings of toxicity.
At 5000 mg/kg bw, reduced motility and apathy was observed lasting for 2 – 4 days.
No macroscopic changes of skin were noted.
Gross pathology:
Sacrificed animals at study termination showed no evidence of macroscopical changes in organs.

Any other information on results incl. tables

Table 1: Acute dermal toxicity of Diuron (male and female rats)

Dose (mg/kg bw)

Number of dead /
number investigated

Time of death (range)

Observations

2500

0/10

-

None

5000

0/10

-

Reduced motility, apathy for 2 – 4 days

LD50value

> 5000 mg/kg bw

 

Applicant's summary and conclusion

Executive summary:

In a reliable study in accordance to OECD 402 rats were dermally exposed to 2500 and 5000 mg/kg bw Diuron. At the low dose level no clinical signs were noted and at the high dose level animals only showed reduced motility and apathy for 2 to 4 days. Therefore, the LD50 is determined to be > 5000 mg/kg bw. (Heimann and Thyssen, 1983)