Phenethyl pivalate

Endpoint summary

Description of key information

The oral LD50 of the test item, Fenethylpivalinate, is higher than 5000 ml/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted similarly to OECD Guideline 401 with deviations: no data about purity and no certificate of analysis of test substance; bodyweight changes were not reported

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no data about purity and no certificate of analysis of test substance; bodyweight changes were not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: SPF albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Source: Central Institute for the Breading of Laboratory Animals TNO, Zeist, The Netherlands
- Weight at study initiation: Males: 156-240 g; females: 136-176 g
- Housing: Animals were housed in groups of five in screen-bottomed stainless steel cages.
- Fasting period before study: Overnight
- Diet: Stock diet, ad libitum
- Water: Tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 1 °C
- Ventilation: Well-ventilated room

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME ADMINISTERED: 5 mL/kg bw

Doses:

5 mL/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes

Statistics:

None

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: equivalent to 4950 mg/kg bw; calculated using the density of 0.99 g/L (literature)

Mortality:

- 3/10 females died between Days 2 and 4 after treatment.

Clinical signs:

other: - Sedation and ataxia were observed within a few hours after treatment and persisted for a few days. - All survivors recovered gradually and appeared healthy at the end of the observation period.

Gross pathology:

- Gross observations at necropsy were normal for all of the surviving animals.

Other findings:

None

None

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 of the test item, Fenethylpivalinate, is higher than 2000 mg/kg bw in rats and therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an acute oral toxicity study performed similarly to OECD Guideline 401, 10 male and 10 female rats of SPF strain were given a single oral dose of the test item, Fenethylpivalinate, at 5 mL/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were macroscopically necropsied after sacrifice.

Three females died between Days 2 and 4 after treatment. Sedation and ataxia were observed within a few hours after treatment and persisted for a few days. All survivors recovered gradually and appeared healthy at the end of the observation period. Surviving animals presented a normal appearance at autopsy. In this study, the combined oral LD50 of the test item, Fenethylpivalinate, in rats was considered to be greater than 5 mL/kg.

The oral LD50 of the test item, Fenethylpivalinate, is higher than 5000 ml/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Acceptable

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

Justification for selection of acute toxicity – oral endpoint
Good quality study, to GLP.

Justification for classification or non-classification

Based on the result of a reliable Acute Oral Toxicity test in rats, calssification under the EU DSD or CLP regulations as acutely toxic by the oral route is not required.

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