3-phenylpropan-1-ol

Endpoint summary

Description of key information

Based on weight of evidence approaches the LD50 for oral and dermal application of the test substance were found to be > 2000 mg/kg bw and < 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

old report but sufficient for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150 - 300 g

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 %

Doses:

1470, 2150, 3160 and 4640 mg/kg bw

No. of animals per sex per dose:

10 animals in the 5000 mg/kg group and 5 animals in each of the other groups were used.

Control animals:

no

Details on study design:

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 250 mg/kg bw

Based on:

test mat.

95% CL:

> 1 680 - < 3 000

Mortality:

In the 5000 mg/kg bw dose group, 9/10 animals died. Mortality occured in all dose groups.

Clinical signs:

other: Clinical signs observed were depression, hypopnea, ataxia and piloerection.

Gross pathology:

Some of the dead rats and of those that were sacrifieced at termination had dark red areas in the lungs.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats, the LD50 was found to be 2250 mg/kg bw.

Executive summary:

An acute oral toxicity study was conducted on rats. First, a dose of 5000 mg/kg bw was tested and 9/10 animals died. Afterwards the following doses were applied: 1470, 2150, 3160 and 4640 mg/kg bw. Depression, hypopnea, ataxia and piloerection were observed and some of the dead animals or those who were sacrificed after study termination had dark red areas in the lungs. Mortality occured in all dose groups. Based on the available results, the LD50 was determined to be 2250 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

old summary of a study report, basic information given

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: individually
- Diet: commercial diet ad libitum
- Water: ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Toxic signs and mortalitiy were recorded daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

The LD50 value was calculated according to Horn's method (Horn, H.J.,Biometric, 12: 311-322, 1956).

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

< 5 000 mg/kg bw

Based on:

test mat.

Mortality:

9/10 animals died

Clinical signs:

other: Depression, hypopnea, ataxia, piloerection

Gross pathology:

Dead rats showed distended stomach.

Interpretation of results:

study cannot be used for classification

Conclusions:

The LD50 was found to be below 5000 mg/kg bw.

Executive summary:

10 rats were adiminstered the test substance at a concentration of 5000 mg/kg bw. As a result, the animals showed depression, hypopnea, ataxia and piloerection and 9 animals died. The dead rats showed distended stomachs. As a result, the LD50 was determined to be <5000 mg/kg bw.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

short summary of study results including only basic information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

670, 1310, 2560, 5000 mg/kg bw

No. of animals per sex per dose:

10 animals per dose (sex not specified)

Control animals:

no

Details on study design:

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

Statistics:

The LD50 was calculated.

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 300 mg/kg bw

Based on:

test mat.

95% CL:

> 1 500 - < 3 100

Mortality:

1 animal in 1310 mg/kg bw dose group died on day 1; 4 from the 2560 mg/kg bw dose group died on day 1 and 1 animal died on day 2; all animals of the 5000 mg/kg bw dose group died on day 1.

Clinical signs:

other: Lethargy was observed from the 1310 mg/kg bw dose group onwards.

Gross pathology:

no data

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats the LD50 value was found to be 2300 mg/kg bw.

Executive summary:

An acute oral toxicity study was conducted on rats. The test substance was applied to 4 groups of 10 rats each in the following concentrations: 670, 1310, 2560 and 5000 mg/kg bw. Lethargy was observed from the 1310 mg/kg bw dose group onwards. All animals of the highest dose group died on day 1 of the study as well as one animal of the 1310 mg/kg bw dose group. 5 animals of the 12560 mg/kg bw dose group died on days 1 and 2. Based on these results, the LD50 was found to be 2300 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 250 mg/kg bw

Quality of whole database:

Old unpublished reports, but basic data given and sufficient for assessment.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: individually
- Diet: commercial diet ad libitum
- Water: ad libitum

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 240 cm2
- % coverage: 10
- Type of wrap if used: rubber sleeve covered with Webril padding

TEST MATERIAL
- Amount applied: 5000 mL/kg bw

Duration of exposure:

24 h

Doses:

5000 mL/kg bw

No. of animals per sex per dose:

6 animals

Control animals:

not required

Details on study design:

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

< 5 000 mg/kg bw

Based on:

test mat.

Mortality:

4 of 6 animals died on days 1, 3 and 4.

Clinical signs:

other: No toxic signs were observed in the surviving animals during the 14 day observation period.

Gross pathology:

The lungs appeared hemorrhagic in 2 animals that had died, 1 animal had white nodules in the liver, in one female both ovaries appeared abscessed.

Interpretation of results:

study cannot be used for classification

Conclusions:

In an acute dermal toxicity study the LD50 was found to be <5000 mg/kg bw.

Executive summary:

An acute dermal toxicity study was conducted on 6 New Zealand white rabbits. 5000 mL/kg bw were applied to the clipped skin sites under occlusion for 24 hours. After this exposure period, the animals were observed for 14 days. 2 rabbits died on day one and two further animals died on days 2 and 3. In two of this animals, the lungs were found to be hemorrhagic, one animal had white nodules in the liver and the ovaries of one female appeared abscessed. Clinical signs were not observed during the whole observation period in the surviving animals. Based on this result, the LD50 value was determined to be < 5000 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

summary of study results, basic information given

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Details on dermal exposure:

TEST MATERIAL
- Amount applied: 2500 mg/kg bw and 5000 mg/kg bw

Duration of exposure:

no data

Doses:

2500 and 5000 mg/kg bw

No. of animals per sex per dose:

4 animals in the low dose group, 6 animals in the high dose group

Control animals:

no

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:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured in the lower dose group, 3 of 6 animals died in the high dose group.

Clinical signs:

other: One rabbit of the high dose group exhibited slight lethargy and one showed flaccid tone. Anorexia and diarrhea were observed in 2 animals.

Gross pathology:

no data

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study the LD50 of the test substance was determined to be approximately 5000 mg/kg bw.

Executive summary:

The test substance was dermally adminstered to rabbits to evaluate the LD50 value. 2500 mg/kg bw were applied to 4 animals and 5000 mg/kg bw were applied to 6 animals. In the low dose group, no animals died and no clinical signs were observed. In the high dose group, slight lethargy, anorexia, diarrhea and flaccid tone were observed and 3 rabbits died. Based on these results, the LD50 value was determined to be approximately 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Old unpublished reports, but basic data given and sufficient for assessment.

Additional information

Acute Toxicity: oral

An acute oral toxicity study was conducted on rats. First, a dose of 5000 mg/kg bw was tested and 9/10 animals died. Afterwards the following doses were applied: 1470, 2150, 3160 and 4640 mg/kg bw. Depression, hypopnea, ataxia and piloerection were observed and some of the dead animals or those who were sacrificed after study termination had dark red areas in the lungs. Mortality occured in all dose groups. Based on the available results, the LD50 was determined to be 2250 mg/kg bw.

10 rats were adiminstered the test substance at a concentration of 5000 mg/kg bw. As a result, the animals showed depression, hypopnea, ataxia and piloerection and 9 animals died. The dead rats showed distended stomachs. As a result, the LD50 was determined to be < 5000 mg/kg bw.

An acute oral toxicity study was conducted on rats. The test substance was applied to 4 groups of 10 rats each in the following concentrations: 670, 1310, 2560 and 5000 mg/kg bw. Lethargy was observed from the 1310 mg/kg bw dose group onwards. All animals of the highest dose group died on day 1 of the study as well as one animal of the 1310 mg/kg bw dose group. 5 animals of the 12560 mg/kg bw dose group died on days 1 and 2. Based on these results, the LD50 was found to be 2300 mg/kg bw.

As a conclusion, the LD50 was found to be > 2000 mg/kg bw and < 5000 mg/kg bw.

Acute toxicity: dermal

An acute dermal toxicity study was conducted on 6 New Zealand white rabbits. 5000 mL/kg bw were applied to the clipped skin sites under occlusion for 24 hours. After this exposure period, the animals were observed for 14 days. 2 rabbits died on day one and two further animals died on days 2 and 3. In two of this animals, the lungs were found to be hemorrhagic, one animal had white nodules in the liver and the ovaries of one female appeared abscessed. Clinical signs were not observed during the whole observation period in the surviving animals. Based on this result, the LD50 value was determined to be < 5000 mg/kg bw.

The test substance was dermally adminstered to rabbits to evaluate the LD50 value. 2500 mg/kg bw were applied to 4 animals and 5000 mg/kg bw were applied to 6 animals. In the low dose group, no animals died and no clinical signs were observed. In the high dose group, slight lethargy, anorexia, diarrhea and flaccid tone were observed and 3 rabbits died. Based on these results, the LD50 value was determined to be approximately 5000 mg/kg bw.

As a conclusion, the LD50 was found to be ca. 5000 mg/kg bw.

Justification for classification or non-classification

On the basis of the available data the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No 2017/776.