Propiophenone

Endpoint summary

Description of key information

Rat LD50 oral: 4490 mg/kg
Dermal LD50 rabbit: 4490 mg/kg

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:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Principles of method if other than guideline:

The experimental method followed the procedure described in earler paper (Smyth et al. 1962).

GLP compliance:

no

Remarks:

pre GLP

Species:

rat

Route of administration:

oral: unspecified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 4 490 other: mg/kg

Based on:

not specified

Remarks on result:

other: 2330 - 8640 mg/kg

Interpretation of results:

not classified

Remarks:

according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 rat: 4490 mg/kg

Executive summary:

The experimental method followed the procedure described in earler paper (Smyth et al. 1962). No further details are available.

Single oral LD50 for rats has been reported to be 4490 (2330 -8640) mg/kg.

Conclusion

LD50 rat: 4490 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 490 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Principles of method if other than guideline:

The experimental method followed the procedure described in earler paper (Smyth et al. 1962).

GLP compliance:

no

Remarks:

pre GLP

Species:

rabbit

Type of coverage:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 4 490 other: mg/kg

Based on:

not specified

Remarks on result:

other: 2110-9540 mg/kg

Interpretation of results:

not classified

Remarks:

according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 rabbit: 4490 mg/kg

Executive summary:

The experimental method followed the procedure described in earler paper (Smyth et al. 1962). No further details are available. Single oral LD50 for rats has been reported to be 4490 (2110 -9540) mg/kg.

Conclusion

LD50 rabbit: 4490 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 490 mg/kg bw

Additional information

The acute toxicity potential of propiophenone has been investigated taking also into consideration data on the structural analogue acetophenone: the Read Across approach can be considered appropriate for the assessement of acute toxicity. Details can be found in the Read Across justification document attached in section 13 of IUCLID.

ORAL ROUTE

An experiment has been performed administrating an oral single dose of propiophenone to rats. The LD50 value has been reported to be 4490 (2330 -8640) mg/kg (Carpenter et al, 1974). Because the available information is reported by literature secondary source and many details, which are foundamental in order to assign a reliability to the study, are lacking, the available data on structural analogous have been taken into account.

It has to be noted that the preparatory work for toxicological evaluations of food additives and contaminants by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) on propriophenone has been conducted. The data on uses and intake requested by the Committee at its fiftythird meeting were provided and raised no safety concern for propiophenone (WHO, 2002).

INHALATION ROUTE

Data on the structural analogue acetophenone are reported in literature monograph. Rowe & Wolf (1963) reported no deaths in rats exposed for 8 hr to an atmosphere saturated with acetophenone [Flash point, 82 °C; vapor pressure (% in saturated air), 0-45 %; evaporation rate (ether = 1), 0-06.] (Opdyke, 1973).

DERMAL ROUTE

An experiment has been performed administrating a dermal single dose of propiophenone to rabbits. The LD50 value has been reported to be 4490 (2110 -9540) mg/kg (Carpenter et al, 1974). Because the available information is reported by literature secondary source and many details, which are foundamental in order to assign a reliability to the study, are lacking available data on structural analogous have been taken into account.

REFERENCE

Opdyke (1973). Monographs on fragrance raw materials: Acetophenone. Food and Cosmetics Toxicology, 11: 99-100

Rowe, V. K. & Wolf, M. A. (1963). Ketones. In Industrial Hygiene and Toxicology. 2nd ed. Edited by F. A. Patty, Vol. II, p. 1763. Interscience Publishers, New York.

World Health Organization (WHO) (2002). Joint FAO/WHO Expert Committee on Food Additives (2001, Rome, Italy) Evaluation of certain food additives and contaminants: fifty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives. (WHO technical report series ; 909) ttp://apps.who.int/iris/bitstream/10665/42578/1/WHO_TRS_909.pdf

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg (i.e. 4490 mg/kg), therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

The dermal LD50 value was established to be higher than 2000 mg/kg (i.e. 4490 mg/kg), which exceeded the highest CLP limit for classification (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).

In conclusion, the test substance is non classified for oral/dermal acute toxicity, according to the CLP Regulation (EC 1272/2008).