[No public or meaningful name is available]

Endpoint summary

Description of key information

oral (rat): LD50 > 5000 mg/kg bw (m+f)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Preliminary study:

Not available.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No deaths occurred and no clinical signs of toxicity or behavioral changes were reported.

Gross pathology:

Not visible lesions observed, except one female rat showed mild hydrometra in uterus.

Other findings:

- Organ weights: No data available.

- Histopathology: No data available.

- Potential target organs: No data available.

- Other observations: No data available.

Table 1. Results

		Male	Female
Dose Level (mg/kg)		5000	5000
Average Body Weight (g)	Initial	230	210
	7 days	291	233
	14 days	323	232
Mortality (No. death/No. dosed)		0/5	0/5
Visible lesions		0/5	1/5 showed mild hydrometra in uterus.

 

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: GHS

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain Albino rats was found to be greater than 5000 mg/kg bodyweight. The test substance was classified as non-toxic.

Executive summary:

In an acute oral toxicity study, 2 groups fasted 7 week old Sprague-Dawley strain Albino rats (five male and five female) were given a single oral dose of undiluted test material at a dose level of   5000  mg/kg bw and observed for14 days. No mortality occurred. No signs of systemic toxicity, or behavioral changes were reported during the study, and no abnormalities were noted at necropsy, except one female rat showed mild hydrometra in uterus. All animals showed expected bodyweight gain during the study except female group during day 7 to day 14 period. The oral LD50 value of test material in rats of both sexes was stimulated to exceed 5000 mg/kg bw.  

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

1 (reliable without restriction)

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Waiver

Additional information

The test material was tested for acute toxicity via oral application to rats. An LD50 of > 5000 mg/kg was identified.No mortality occurred. No signs of systemic toxicity, or behavioral changes were reported during the study, and no abnormalities were noted at necropsy, except one female rat showed mild hydrometra in uterus. All animals showed expected bodyweight gain during the study except female group during day 7 to day 14 period.

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the test item with regard to acute toxicity. The substance is not classified for acute toxicity via oral route in accordance with the CLP Regulation (EC) No 1272/2008.