[No public or meaningful name is available]

Endpoint summary

Description of key information

In an acute oral toxicity study according to OECD guideline 423 (acute oral toxicity - acute toxic class method), the LD50 was >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

Study period:

2007-10-10 to 2007-11-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted December 17, 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

HsdRccHan : WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Females nulliparous and non-pregnant: yes
- Age at study initiation: not specified
- Weight at study initiation: 152 - 204 g
- Fasting period before study: overnight, after administration of the test item the food was withheld for for further 3- 4 h
- Housing: Macrolon cages on Altromin saw fiber bedding
- Diet (ad libitum): Altromin 1324 maintanenance diet for rats and mice, specific pathogen-free
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
- Microbiological status: SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: non-toxic characteristics
- Amount of vehicle: 10 mL
- Lot no.: 066K0057

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

300 mg/kg bw
2000 mg/kg bw

No. of animals per sex per dose:

3 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to treatment and once a week thereafter
- Necropsy of survivors performed: yes
- Clinical signs: yes, several times on the day of dosing and once a day thereafter
- Other examinations performed: no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: No treatment related effect was observed in any animal of any step.

Gross pathology:

Effects on organs: No treatment realated effect was observed in any animal of any step.

Table 1: Absolute body weights in g

Animal No./ Sex	Day 0	Day 7	Day 14
Step 1 (300 mg/kg bw)
1/ female	152	190	193
2/ female	194	205	210
3/ female	204	230	239
Step 2 (300 mg/kg bw)
1/ female	168	204	200
2/ female	165	193	194
3/ female	160	185	200
Step 3 (2000 mg/kg bw)
1/ female	170	197	200
2/ female	160	185	199
3/ female	167	194	194
Step 4 (2000 mg/kg bw)
1/ female	168	178	182
2/ female	180	200	202
3/ female	172	191	193

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the reported data of this toxicity test it can be stated that the test item Beta 30 showed no orally toxic characteristics, the LD50 was >2000 mg/kg bw.

Executive summary:

The acute toxic class method according to OECD 423 was performed with the test item Beta 30. In the first and second step, the test item was given at a dose of 300 mg/kg bw to a group of 3 female rats (HsdRccHan : WIST) via gavage. No compound related mortality was recorded for any of the treated animals in step 1 and 2. Based on these results and in accordance with the acute toxic class regime, the third and fourth steps of the test were performed with 2000 mg/kg bw with further groups of 3 female rats. No compound related mortality was observed in step 3 and 4. A clinical examination did not reveal any signs of toxicity in any animal and test step. Further, no treatment related gross pathological changes were found in any animal and test step. Throughout the 14-days observation period, no weight loss was recorded for any animal. The weight gain was within the expected range.

The test item Beta 30 was concluded to show no oral toxicity, the LD50 was >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

The acute toxic class method according to OECD 423 was performed with the test item. In the first and second step, the test item was given at a dose of 300 mg/kg bw to a group of 3 female rats (HsdRccHan : WIST) via gavage. No compound related mortality was recorded for any of the treated animals in step 1 and 2. Based on these results and in accordance with the acute toxic class regime, the third and fourth steps of the test were performed with 2000 mg/kg bw with further groups of 3 female rats. No compound related mortality was observed in step 3 and 4. A clinical examination did not reveal any signs of toxicity in any animal and test step. Further, no treatment related gross pathological changes were found in any animal and test step. Throughout the 14-days observation period, no weight loss was recorded for any animal. The weight gain was within the expected range.

The test item was concluded to show no oral toxicity, the LD50 was >2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

 

Oral toxicity

Based on available data on acute toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.