Benzyl propionate

Endpoint summary

Description of key information

In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw.

The LD50 value for acute dermal toxicity was determined to be greater than 5000 mg/kg bw in rabbits.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Route of administration:

oral: unspecified

Doses:

2050, 2560, 3200, 4000 and 5000 mg/kg bw

No. of animals per sex per dose:

10

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 300 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 030 - <= 3 570

Mortality:

2050 mg/kg bw: none
2560 mg/kg bw: 4/10
3200 mg/kg bw: 5/10
4000 mg/kg bw: 9/10
5000 mg/kg bw: 9/10

Clinical signs:

other: 2050 mg/kg bw: none all higher doses: lethargy, pilorection, tremors, chromodacryorrhea

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of the test item was determined in rats. The study was conducted with 10 rats per group. The test item was administered in doses of 2050, 2560, 3200, 4000 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2560 mg/kg bw onwards. Lethargy, pilorection, tremors, chromodacryorrhea were observed at doses from 2560 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 300 mg/kg bw

Quality of whole database:

Similar to Guideline with sufficient details for assessment.

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:

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

no data

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Other findings:

Skin irritation: moderate redness in 1 of 5 animals

Interpretation of results:

GHS criteria not met

Conclusions:

A LD50 value greater than 5000 mg/kg bw was determined in a dermal toxicity in rabbits after treatment with the test item.

Executive summary:

To assess the acute dermal toxicity potential of the test item, a study equivalent to OECD TG 402 was performed. Five rabbits were each incubated with the limit dose of 5000 mg/kg bw. No clinical signs and no mortality was observed. Moderate redness was observed in one animal.

Based on the results of this study, the LD50 value for acute dermal toxicity was determined to be greater than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Similar to Guideline with sufficient details for assessment.

Additional information

Acute oral toxicity

The acute oral toxicity of the test item was determined in rats. The study was conducted with 10 rats per group. The test item was administered in doses of 2050, 2560, 3200, 4000 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2560 mg/kg bw onwards. Lethargy, pilorection, tremors, chromodacryorrhea were observed at doses from 2560 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw.

Acute dermal toxicity

To assess the acute dermal toxicity potential of the test item, a study equivalent to OECD TG 402 was performed. Five rabbits were each incubated with the limit dose of 5000 mg/kg bw. No clinical signs and no mortality was observed. Moderate redness was observed in one animal.

Based on the results of this study, the LD50 value for acute dermal toxicity was determined to be greater than 5000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No 1272/2008,

as amended for the tenth time in Regulation (EC) No 2017/776.