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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
Not applicable
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

Table 1: individual bodyweights

Dose (mg/kg)

Sex

Animals

Day 1

Body weight gain

Day 8

Body weight gain

Day 15

2000

Male

01

270

39

309

53

362

02

248

53

301

65

366

03

216

43

259

51

310

04

253

56

309

69

378

05

247

40

287

50

337

Mean

247

46

293

58

351

SD

20

8

21

9

27

2000

Female

06

237

0

237

23

260

07

244

2

246

8

254

08

234

12

246

22

268

09

235

13

248

18

266

10

249

-2

247

7

254

Mean

240

5

245

16

260

SD

6

7

4

8

7

Table 2: cutaneaous reactions

Time

Animals

Cutaneous reactions

Males

Females

D 2

5/5

5/5

None

D 3

4/5

 

Discrete erythema

1/5

2/5

Moderate erythema

 

2/5

Severe erythema

 

1/5

Moderate erythema, crusts

D 4

 

2/5

Dryness of the skin,moderate erythema

 

3/5

Moderate erythema

2/5

 

Dryness of the skin,discrete erythema

3/5

 

None

D 5

2/5

1/5

Dryness of the skin

 

1/5

Moderate erythema

 

3/5

Dryness of the skin,discrete erythema

3/5

 

None

D 6

2/5

2/5

Dryness of the skin

3/5

 

None

 

3/5

Dryness of the skin, discrete erythema

D 7

2/5

4/5

Dryness of the skin

3/5

1/5

None

D 8 and D 9

1/5

 

Crusts, dryness of the skin

4/5

3/5

Dryness of the skin

 

2/5

None

D 10 and D 11

5/5

3/5

Dryness of the skin

 

2/5

None

D12 to D 15

5/5

5/5

None

Applicant's summary and conclusion