2-Propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]-

Endpoint summary

Description of key information

DPNG 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:

2020-06-02 to 2020-07-16

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)

Version / remarks:

December 17, 2001

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)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: eight weeks
- Weight at study initiation: 192.4 to 204.9g (1st step); 193.1 to 199.0 g (2nd step); individual body weights at the administration of the 2nd step were confirmed to be within +-20% of the mean animal weight at the administration of the 1st step.
- Fasting period before study:
- Housing: three animals per cage or fewer; after group allocation, animals were housed individually until the administration day; hanging stainless steel cages with mesh-floor
- Historical data: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Quarantined/Acclimatized: six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light
- Fasting period: 17-19 hours before administration; 3-4 hours after administration

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% (w/v)
- Justification for choice of vehicle: Pretests: Although the test substance did not dissolved and was not suspended to purified water or purified water including 3 v/v% of polyoxyethylene(20) sorbitan monooleate at a concentration of 20 w/v%, the test substance was dissolved to olive oil at a concentration of 20 w/v%. The condition of the formulation such as colour did not change at room temperature four hours after the preparation. Therefore, olive oil was selected as a vehicle.
SUBSTANCE
- Lot/batch no. (if required): 191224
- Purity: 98.8

MAXIMUM DOSE VOLUME APPLIED: 10 mL/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
- Frequency of observations and weighing: Clinical observation: continuously for 10 minutes after the administration, and 30 min., 1 hour, 3 hours and 5 hours after admin. afterwards once per day from day 1-14.; body weights on day 0, 1,7 and 14
- Necropsy of survivors performed: yes

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality or moribundity occurred at 2000 mg/kg and no abnormalities were observed in any animal in the general clinical observation or necropsy

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

a decrease was noted in one animal (out of three) of 1st step seven days after administration (-2.7 g). The decrease of the body weight was considered as physiological fluctuation since no abnormalities were observed in the general clinical observation one day after the administration and thereafter, body weights of the other days and gross necropsy, and since a body weight decrease is generally observed in females which are eight weeks old and more. No abnormalities in the 2nd step.

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

or unclassified

Conclusions:

DPNG does not fulfill the criteria for CLP classification as acute toxic for the oral pathway.

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

Justification for classification or non-classification

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