Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/01/1997 - 09/12/1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Version / remarks:
(1982)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 59 NohSan No. 4200 (1985)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
powder

Test animals

Species:
rat
Strain:
other: Crl:CD[SD]BR (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8 to 16 weeks old
- Weight at study initiation: 254 to 290 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
VEHICLE
- Concentration of vehicle: 0.5 % CMC in distilled water
- Total volume applied: 0.5 mL
- Justification for choice of vehicle: no data

TEST SITE
- Area of exposure: The formulation was applied to the test sites at approximately 0.03 g/cm² to an area of 16 cm².
- Washing: Washed with tap water
- Total volume applied: 2 mL/ kg dinotefuran
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
no
Details on study design:
- Duration of test/exposure period: 24 hours
- Rational for dose level selection: Based on the requirements of the regulatory test guidelines.
- Post exposure observation period: 14 days
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
There were no treatment-related clinical signs of toxicity, although 2 females showed red-stained face on the day of treatment.
Transient slight to moderate erythema, associated with slight edema in one animal, occurred in 8 of the 10 animals on the day of patch removal (Table 1). Slight erythema persisted in 2 animals until day 7, but thereafter no dermal reactions were evident.
Body weight:
All male animals gained weight throughout the study, but 4 females during the first week and 2 females during the second week showed minor weight losses of up to 9g .
Gross pathology:
There were no macroscopic findings at necropsy in any animal.

Any other information on results incl. tables

Table 1: Mean group dermal irritation scores

Sex

Observation

Group mean dermal irritation scores on day:

 

 

1

3

7

10

14

Male

Erythema

1.60

1.0

0.40

0

0

 

Edema

0.20

0.40

0

0

0

 

Atonia

0

0

0

0

0

 

Desquamation

0

0

0

0

0

 

Coriaceousness

0

0

0

0

0

 

Fissuring

0

0

0

0

0

Female

Erythema

0.60

0.20

0

0

0

 

Edema

0

0

0

0

0

 

Atonia

0

0

0

0

0

 

Desquamation

0

0

0

0

0

 

Coriaceousness

0

0

0

0

0

 

Fissuring

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) was estimated to be greater than 2000 mg/kg in both sexes. Accordingly, in the EU dinotefuran does not require classification under the provisions of Commission Directive 93/21/EEC, Annex VI (1993), and no risk phrase is required in respect of dermal exposure (US EPA category III, GHS category 5).