IPEMA

Endpoint summary

Description of key information

IPEMA does not fulfill the criteria for classification as acute toxic for the oral pathway under CLP

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:

2020-06-09 to 2020-06-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan (Hino Breeding Center)
- Age at study initiation: 8 weeks
- Weight at study initiation: 188.8 - 205.5 g
- Fasting period before study: 17 to 18 hours before administration, and for three to four hours after administration
- Housing: animals were kept in hanging stainless steel cages with mesh-floor (165Wx300Dx150H mm)
- Historical data: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 -12 per hour
- Photoperiod (hrs dark / hrs light): 12h/12h

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% (w/v)
- Justification for choice of vehicle: test substances dissolved in olive oil at a concentration of 20%.
The condition of the formulation such as color did not change at RT for hours after the preparation
- Lot/batch no. (if required): 191224
- Purity: 99.5%

MAXIMUM DOSE VOLUME APPLIED:
Dose level 2000 mg/kg
Dosing volume 10mL/kg

Doses:

1. step: animal 1-3: dose 2000 mg/kg
2. step: animal 4-6: dose 2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Clinical signs including body weight : the animals were observed continously for 10 minutes after the administration, and observed 30 minutes and three hours after the administration on the administration day. The animals were observed once int he morning from 1 to 14 days after the administration. Body weights were measured 0 (before administration, 1, 7 and 14 days after the adminsitration. Body weight changes were calculated.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

in the 1st or 2nd step at 2000 mg/kg no mortality nor moribundity occurred. No abnormalities were observed in the animals

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

In the 1st step at 2000 mg/kg, no abnormalities were observed in any animal. In the 2nd step at 2000 mg/kg a decrease (-0.8g) from the previous weight was noted in one animal out of the three 14 days after the administration. The decrease of the body weight was considered as physiological fluctuation since no abnormalities were observed in the general clinical observation, body weights of the other days or gross necropsy and since a body weight decrease is generally observed in females which are eight weeks old and more.

Gross pathology:

no abnormalities were observed in any animals

Body weights

Step	Dose (mg/kg)	Animal No.	Body weights (g)
			Day after administration
			Initial	1	7	14
1st	2000	1	194.0	208.6 (14.6)	240.6 (32.0)	263.5 (22.9)
		2	192.2	200.7 (8.5)	228.8 (28.1)	238.0 (9.2)
		3	188.8	198.7 (9.9)	231.6 (32.9)	244.6 (13.0)
2nd		4	194.7	210.4 (15.7)	239.9 (29.2)	274.8 (34.9)
		5	190.9	207.8 (16.9)	235.3 (27.5)	239.1 (3.8)
		6	205.5	221.4 (15.9)	230.8 (9.4)	230.0 (-0.8)

Figures in parentheses indicate differences from previous body weight.

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

or unclassified

Conclusions:

IPEMA does not fulfill the criteria for CLP classification as acute toxic for the oral pathway under CLP. LD50 >2000 mg/kg

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

Endpoint conclusion

Endpoint conclusion:

no study available