dinotefuran (ISO); 1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Version / remarks:

(1982)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF 59 NohSan No. 4200 (1985)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine

EC Number:

605-399-0

Cas Number:

165252-70-0

Molecular formula:

C7H14N4O3

IUPAC Name:

(RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine

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 or test system 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:

other: 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 o

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 according to the CLP regulation.