Geranyl butyrate

Endpoint summary

Description of key information

Geranyl butyrate is likely to be non hazardous by oral and dermal route of exposure.

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:

other: Data is form peer-reviewed journal

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acut eoral toxicity study of geranyl butyrate in rats

GLP compliance:

not specified

Test type:

other: No data

Limit test:

no

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:No data
- Age at study initiation:Young adult rat
- Weight at study initiation:No data
- Fasting period before study: Animals were fasted for approximately 18 hr prior to treatment.
- Housing:Animals were housed in cages
- Diet (e.g. ad libitum): ad libitum, food was replaced in cages as soon as animals received thcir respective doses.
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period:No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: To: No data

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No data available

Doses:

No data available

No. of animals per sex per dose:

5 male, 5 female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain
- Other examinations performed: clinical signs, body weight were examined.

Statistics:

LDso's were computed by the method of Litchfield & Wi)coxon (1949).

Preliminary study:

No data available

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

10 660 mg/kg bw

Based on:

test mat.

95% CL:

> 8 020 - < 14 180

Remarks on result:

other: No effect on survival and clinical sign

Mortality:

Animals were dead after 4 days of dose administration.

Clinical signs:

Marked signs of depression and coma observed on higher dose value.

Body weight:

No data available

Gross pathology:

No data available

Other findings:

No data available

Interpretation of results:

practically nontoxic

Conclusions:

LD50 was considered to be 10660 mg/kg bw (8020-14180 mg/kg) when Osborne-Mendel male and female rats were treated with Geranyl butyrate orally by gavage.

Executive summary:

In a acute oral toxicity study, 10 Osborne-Mendel male and female rats were treated wtih Geranyl butyrate orally by gavage and observed for 14 days. Animals were dead after 4 days of dose administration. Marked signs of depression and coma observed on higher dose value. Based on the observation acute lethal dose were calculated as 10660 mg/kg bw with the 95% confidence limit of 8020-14,180 mg/kg. Therefore, LD50 was considered to be 10660 mg/kg bw (8020-14180 mg/kg) when Osborne-Mendel male and female rats were treated with Geranyl butyrate orally by gavage.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 660 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from peer reviewed journal

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:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer-reviewed journal

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute oral toxicity studyof geranyl butyrate by dermal rout e on rats

GLP compliance:

not specified

Test type:

other: No data

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data available

Type of coverage:

other: Dermal

Vehicle:

not specified

Details on dermal exposure:

No data available

Duration of exposure:

No data available

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

No data available

Control animals:

not specified

Details on study design:

No data available

Statistics:

No data available

Preliminary study:

No data available

Sex:

not specified

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50 % motality observed

Mortality:

50% mortality was observed in treated rabbits.

Clinical signs:

No data available

Body weight:

No data available

Gross pathology:

No data available

Other findings:

No data available

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 was considered to be 5000 mg/kg bw when rabbits were treated with Geranyl butyrate dermally.

Executive summary:

In a acute dermal toxicity study, rabbits were treated with Geranyl butyrate dermally. 50% mortality was observed in treated rabbits. Therefore, LD50 was considered to be 5000 mg/kg bw when rabbits were treated with Geranyl butyrate dermally.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from peer-reviewed journal

Additional information

Acute oral toxicity:

Based on the data available for target Geranyl butyrate (CAS no 106-29-6) and its read across Citronellyl isobutyrate (CAS no 97-89-2) for acute oral toxicity is summarized below

In a study conducted by Jenneret al(1964, 1979), acute oral toxicity was evaluated in 10 Osborne-Mendel male and female rats by using Geranyl butyrate orally by gavage and observed for 14 days. Animals were dead after 4 days of dose administration. Marked signs of depression and coma observed on higher dose value. Based on the observation acute lethal dose were calculated as 10660 mg/kg bw with the 95% confidence limit of 8020-14,180 mg/kg. Therefore, LD50 was considered to be 10660 mg/kg bw (8020-14180 mg/kg) when Osborne-Mendel male and female rats were treated with Geranyl butyrate orally by gavage.

Based on the prediction done by usingQSAR Toolbox 3.4.(2016), acute oral toxicity was estimated in Tif:RAIf (SPF) male and female rats by using butanoic acid, 3,7-dimethyl-2,6-octadienyl ester, (e)-orally by gavage. 50 % mortality was observed in treated rats at 3264.8 mg/kg bw. Therefore, estimated LD50 was considered to be 3264.8 mg/kg bw when Tif:RAIf (SPF) male and female rats were treated with butanoic acid, 3,7-dimethyl-2,6-octadienyl ester, (e)- orally by gavage.

Based on the prediction done by using Danish (Q) SAR Database (2016), acute oral toxicity was estimated in mice by using Geranyl butyrate orally. 50 % mortality was observed in treated mice at 4600 mg/kg bw. Therefore, estimated LD50 was considered to be 4600 mg/kg bw when mice were treated with Geranyl butyrate orally.

In a study conducted by Denineet al(1979) for read across, acute oral toxicity was evaluated in rats by using Citronellyl isobutyrate in the concentration of 5000 mg/kg bw orally. No mortality was observed in treated rats at 5000 mg/kg bw. Therefore, LD50 was considered to be > 5000 mg/kg bw when rats were treated with Citronellyl isobutyrate orally.

Thus, based on the data available target Geranyl butyrate (CAS no 106-29-6) and its read across Citronellyl isobutyrate (CAS no 97-89-2) is likely to be non hazardous by oral route of exposure.

Acute dermal toxicity:

Based on the data available for target Geranyl butyrate (CAS no 106-29-6) and across Citronellyl isobutyrate (CAS no 97-89-2) for acute oral toxicity is summarized below

In a study conducted by Shelanskiet al(1979), acute dermal toxicity was evaluated in rabbits by using Geranyl butyrate dermally. 50% mortality was observed in treated rabbits. Therefore, LD50 was considered to be 5000 mg/kg bw when rabbits were treated with Geranyl butyrate dermally.

Based on the prediction done by usingQSAR Toolbox 3.4(2016), acute dermal toxicity was estimated in
New Zealand Whitemale and female rabbits by using butanoic acid, 3,7-dimethyl-2,6-octadienyl ester, (e)- dermally by occlusive application moistened with 0.9% saline. 50 % mortality was observed in treated rabbits at 3329 mg/kg bw. Therefore, estimated LD50 was considered to be 3329 mg/kg bw whenNew Zealand Whitemale and female rabbits were treated with butanoic acid, 3,7-dimethyl-2,6-octadienyl ester, (e)- dermally by occlusive application.

In a study conducted by Denineet al(1979) for read across, acute dermal toxicity was evaluated in rabbits by using Citronellyl isobutyrate in the concentration of 5000 mg/kg bw orally. No mortality was observed in treated rats at 5000 mg/kg bw. Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with Citronellyl isobutyrate dermally.

Thus, based on the data available target Geranyl butyrate (CAS no 106-29-6) and its read across Citronellyl isobutyrate (CAS no 97-89-2) is likely to be non hazardous by dermal route of exposure.

Justification for selection of acute toxicity – oral endpoint

LD50 was considered to be 10660 mg/kg bw (8020-14180 mg/kg) when Osborne-Mendel male and female rats were treated with Geranyl butyrate orally by gavage.

Justification for selection of acute toxicity – dermal endpoint

LD50 was considered to be 5000 mg/kg bw when rabbits were treated with Geranyl butyrate dermally.

Justification for classification or non-classification

Based on the data available target Geranyl butyrate (CAS no 106-29-6) and its read across Citronellyl isobutyrate (CAS no 97-89-2) is likely to be non hazardous by oral and dermal route of exposure.