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Diss Factsheets

Administrative data

Description of key information

LD50 oral for Atlen SK is > 2000 mg/kg bw
LD50 dermal for Atlen SK is > 2000 mg/kg bw

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)
Rationale for reliability incl. deficiencies:
other: this study was planned and executed in accordance with relevant guidelines as well as the requirements of the GLP
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: conventional husbandry of Institute of Occupational Medicine, Łódź, Poland
- Age at study initiation: 10 weeks
- Weight at study initiation: see Table 2 in section Any other information on results incl. tables
- Fasting period before study: the day before the start of the experiment (about 19 hrs before administration of the test item) the food was withheld. Water was still available. The food was restored 3 hours after administration of the test item.
- Housing: The animals were kept in cages with plastic bottom and wired lid of dimensions: (length x width x height) 58 x 37 x 21 cm. The animals were kept in the cages individually (the sighting study) or four rats per cage (the main study). UV sterilized wooden shaving were used as the bedding.
- Diet (e.g. ad libitum): ad libitum. The animals were given standard granulated "Murigran" foodstuff produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz, Poland
- Water (e.g. ad libitum): ad libitum. The animals were given tap water.
- Acclimation period: prior to the start of the dosing the animals were quarantined and observed daily for at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 37 - 60
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 (artificial light)
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 400 mg/ml
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: corn oil is typically used in oral acute toxicity studies and it is compatibile with Atlen SK

MAXIMUM DOSE VOLUME APPLIED: 0.5 ml per 100 g of bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: evaluation of general condition of animals was conducted twice a day (once on days off). detailed clinical observations were performed at the day of administration after 10, 30 and 60 minutes since administration and then in hourly intervals - till the 5th hour after administration. From 1st to 14th day of the observation period clinical observations were performed once a day. bw of animals was individually determined directly before administration of the test item (day 0) and then on 7th and 14th day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Preliminary study:
The sighting study performed on a single animal at the dose of 2000 mg/kg bw revealed no signs of toxicity.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the test.
Clinical signs:
other: No clinical signs were stated during the test in any of the animals - see Table 1 in the section Any other information on results incl. tables.
Gross pathology:
No pathological changes in any of the animals were stated at the necropsy.

Table 1. Atlen SK Acute oral toxicity on rats – clinical signs – overall list

Dose

(mg/kg

b.w.)

Day after

administration

Number

of alive

animals

Rat No.

1*

2

3

4

5

2000

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

* female from the sighting study

NC = no changes

 

 

Table 2. Atlen SK Acute oral toxicity on rats – body weight of animals (g)

Dose

(mg/kg

b.w.)

Rat No.

Day of experiment

Body weight gain

(0 →14)

0

7

14

2000

1*

2

3

4

5

196

210

208

209

214

210

238

237

234

230

235

248

254

230

246

39

38

46

21

32

* female from the sighting study

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As median oral acute dose (LD50) for Atlen SK is > 2000 mg/kg it is not classified as dangerous in accordance with both the DSD and the CLP regulation.
Executive summary:

Presented results originate from a guideline study conducted in accordance with the requirements of the GLP. Hence, this information can be considered reliable and suitable for use as the key study for this endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

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)
Rationale for reliability incl. deficiencies:
other: this study was planned and executed in accordance with relevant guidelines as well as the requirements of the GLP
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
Few times during the quarantine air temperature exceeded 25 °C. It had no influence on the study course and results.
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: conventional husbandry of Institute of Occupational Medicine, Łódź, Poland
- Age at study initiation: females 9 weeks, males 10 weeks
- Weight at study initiation: see Table 2 in the section Any other informartion on results incl. tables
- Fasting period before study: animals were not fasted prior to the experiment
- Housing: The animals were kept in cages with plastic bottom and wired lid of dimensions (length x width x height) 58 x 37 x 21 cm. After application of the test item each animal was kept individually in a cage. After removal of the test item from the skin, during the following days of the experiment, animals were kept five per cage, each sex separately. UV-sterilized wooden shavings were used as the bedding.
- Diet (e.g. ad libitum): ad libitum. The animals were given standard granulated "Murigran" fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz, Poland
- Water (e.g. ad libitum): ad libitum, The animals were given tap water.
- Acclimation period: the animals were quarantined and observed daily for at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 40 - 70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
other: The test item was held in contact with the skin with a porous gauze dressing
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: masel 42 cm2, females 36 cm2
- % coverage: ca. 10
- Type of wrap if used: the gauze patches were covered with PVC foil and elastic bandage was used to make circular protecting band

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test item was removed from the skin using water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: evaluation of general condition of animals was performed twice a day (once a day on days off). Detailed clinical observations were performed at hourly intervals after administration of the test item (day 0). From 1st to 14th day of the observation period detailed clinical observations were performed once a day. bw of animals was individually determined for each animal directly before administration of the test item and then on the 7th and the 14th day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the test.
Clinical signs:
other: Following administration of the test item, no pathological changes were stated on skin of males and females. No other clinical signs were stated during the test in any of the animals - see Table 1 in the section Any other information on results incl. tabl
Gross pathology:
No pathological changes were stated in animals at the necropsy.

Table 1. Acute dermal toxicity study on rats – clinical signs – overall list

Dose

mg/kg bw

Sex

Day after administration

No. of alive animals

Rat No.

1

2

3

4

5

2000

males

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

females

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

5

5

5

5

5

5

5

5

5

5

5

5

5

5

5

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC

NC – no changes

 

Table 2. Acute dermal toxicity study on rats – body weight of animals (g)

Dose

mg/kg bw

Sex

Rat No.

Day

Body weight gain

(0→14)

0

7

14

2000

males

1

2

3

4

5

315

297

282

297

279

325

311

299

305

294

349

343

312

314

309

34

46

30

17

30

females

1

2

3

4

5

217

213

211

223

211

236

218

222

233

211

249

242

239

251

227

32

29

28

28

16

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As median dermal acute dose (LD50) for Atlen SK is > 2000 mg/kg it is not classified as dangerous in accordance with both the DSD and the CLP regulation.
Executive summary:

Presented results originate from a guideline study conducted in accordance with the requirements of the GLP. Hence, this information can be considered reliable and suitable for use as the key study for this endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute toxicity of Atlen SK was tested in vivo via the oral and the dermal route.

In acute oral toxicity study of Atlen SK no signs of toxicity were stated at the limit dose of 2000 mg/kg bw.

In acute dermal toxicity study of Atlen SK no signs of toxicity were stated at the limit dose of 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
One study available.

Justification for selection of acute toxicity – dermal endpoint
One study available.

Justification for classification or non-classification

Data available for Atlen SK is conclusive but not sufficient for the classification of Atlen SK with regard to acute toxicity.