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Administrative data

Description of key information

LD50>2000 mg/kg bw in a limit test by oral route.
LD50>2000 mg/kg bw in a limit test by dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
Not applicable
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

None

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Well conducted and described study in accordance with GLP and OECD guideline 423 without any deviation.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
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
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
semiocclusive
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
GLP study conducted in compliance with international guidelines without any deviation.

Additional information

In an acute oral class method toxicity study performed in accordance with GLP and OECD guideline 423, no mortality and no clinical signs were observed in Sprague Dawley rats given a single oral dose of Chimexane NV in purified water at the limit test dose of 2000 mg/kg bw.

In an acute dermal toxicity study performed in accordance with GLP and OECD guideline 402, no mortality was observed in Sprague Dawley rats given a single dose of Chimexane NV at the limit test dose of 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only one study available for this endpoint

Justification for selection of acute toxicity – inhalation endpoint
The test substance is most of the time a pasty solid, so the potential for the generation of inhalable forms is unlikely. The substance is liquid and around 100°C during conditioning phase; sufficient RMM are already used during this phase, as workers are protected with intensive gloves, protective clothings and headgear as well as a local extraction ventilation. In addition, no acute toxic effects were identified in acute toxicity studies by oral and dermal routes. As this route of exposure is not significant and that no acute toxic effects are expected, an acute inhalation toxicity study is not deemed necessary.

Justification for selection of acute toxicity – dermal endpoint
Only one study available for this endpoint

Justification for classification or non-classification

Oral and dermal LD50 are higher than 2000 mg/kg bw in rats therefore Chimexane NV does not need to be classified for acute toxicity according to the Annex VI to the Directive 67/548/CEE and the CLP Regulation (EC) N° (1272/2008).