4-methoxybenzyl alcohol

Endpoint summary

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the given test chemical. The LD50 value is 1200 mg/kg bw. The study concluded that the LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.

Acute Inhalation Toxicity:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0018 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is 3000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

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:

data from handbook or collection of data

Justification for type of information:

Data is from Publication.

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of the given test chemical was performed in rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 18 hour fasted

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

not specified

Doses:

1.2 ml/kg (approximately 1.34 g/kg).

No. of animals per sex per dose:

50

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical signs.

Statistics:

not specified

Preliminary study:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 200 mg/kg bw

Based on:

test mat.

Mortality:

50% mortality was observed at 1200 mg/kg bw in treated animals.

Clinical signs:

other: Severe depression and dyspnoea were reported prior to death.

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Acute oral toxicity dose (LD50) value was considered to be 1200 mg/kg bw, when 50 rats were treated with the given test chemical via oral route.

Executive summary:

Acute oral toxicity study was conducted by using the given test chemical in 50 rats at the dose concentration of 1.2 ml/kg (approximately 1.34 g/kg).

Animals were observed for mortality and clinical signs for 6 days.

50% mortality was observed at 1200 mg/kg bw in treated animals. Severe depression and dyspnoea were reported prior to death.

Hence, the LD50 value was considered to be 1200 mg/kg bw, when 50 rats were treated with the given test chemical via oral route.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 200 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from publication.

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:

Endpoint conclusion

Quality of whole database:

Waiver

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:

data from handbook or collection of data

Justification for type of information:

Data is from Publication.

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute dermal toxicity study of the given test chemical was performed in rabbit.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Type of coverage:

other: Dermal

Vehicle:

not specified

Details on dermal exposure:

not specified

Duration of exposure:

not specified

Doses:

1.25, 2.5, and 5.0 g/kg.

No. of animals per sex per dose:

Groups of four rabbits

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 6 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical signs.

Statistics:

not specified

Preliminary study:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 000 mg/kg bw

Based on:

test mat.

95% CL:

1 940 - 4 060

Mortality:

Mortalities included one rabbit from the 2.5 g/kg group on day 1, and all four rabbits from the 5.0 g/kg group by day 6.

Clinical signs:

other: Clinical signs of toxicity included loss of coordination and muscle tone in two animals at 5.0 g/kg and one animal at 2.5 g/kg. Slight to moderate erythema and edema was also observed in all animals.

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

Acute dermal toxicity dose (LD50) value was considered to be 3.0 g/kg, with 95% confidence limits of 1.94–4.06 g/kg, when Groups of four rabbits were treated with the given test chemical by dermal application.

Executive summary:

Acute dermal toxicity study was conducted by using the given test chemical in Groups of four rabbits at the dose concentration of 1.25, 2.5, and 5.0 g/kg. Animals were observed for mortality and clinical signs for 6 days.

Mortalities included one rabbit from the 2.5 g/kg group on day 1, and all four rabbits from the 5.0 g/kg group by day 6. Clinical signs of toxicity included loss of coordination and muscle tone in two animals at 5.0 g/kg and one animal at 2.5 g/kg. Slight to moderate erythema and edema was also observed in all animals.

Hence, the LD50 value was considered to be 3.0 g/kg, with 95% confidence limits of 1.94–4.06 g/kg, when Groups of four rabbits were treated with the given test chemical by dermal application.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from publication.

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and mice for the given test chemical. The studies are summarized as below –

 

The acute oral toxicity study was mentioned in peer-reviewed journals, handbook, authoritative databases and secondary reports and conducted to assess the toxicological profile of the given test chemical in 50 rats at the dose concentration of 1.2 ml/kg (approximately 1.34 g/kg). Animals were observed for mortality and clinical signs for 6 days. 50% mortality was observed at 1200 mg/kg bw in treated animals. Severe depression and dyspnoea were reported prior to death. Hence, the LD50 value was considered to be 1200 mg/kg bw, when 50 rats were treated with the given test chemical via oral route.

 

The above study report is supported with another study mentioned in different publications, handbooks, authoritative databases and secondary reports for the given test chemical. The oral toxicity study was conducted by using the given test chemical in 90 mice at the dose concentration of 1.6 ml/kg (approximately 1.78 g/kg). Animals were observed for mortality and clinical signs for 6 days. 50% mortality was observed at 1600 mg/kg bw in treated animals. Severe depression and dyspnoea were reported prior to death. Hence, the LD50 value was considered to be 1600 mg/kg bw, when 90 mice were treated with the given test chemical via oral route.

 

All these studies are supported with the data available in publication, different handbooks and authoritative database for the test chemical. The acute oral toxicity study was conducted in rats at the dose concentration of 1400 mg/kg bw. Animals were observed for mortality and clinical signs. 50% mortality was observed at 1400 mg/kg bw. The observed effects were haematological Changes, anaemia and nephrotoxicity. Hence, the LD50 value was considered to be 1400 mg/kg bw, when rats were treated with the given test chemical via oral route.

 

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.

 

Acute Inhalation Toxicity:

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0018 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal Toxicity:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents,

i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below -

 

The reported study was mentioned in peer-reviewed journals and authoritative databases and conducted to determine acute dermal toxicity dose for the given test chemical in Groups of four rabbits at the dose concentration of 1.25, 2.5, and 5.0 g/kg.

Animals were observed for mortality and clinical signs for 6 days. Mortalities included one rabbit from the 2.5 g/kg group on day 1, and all four rabbits from the 5.0 g/kg group by day 6. Clinical signs of toxicity included loss of coordination and muscle tone in two animals at 5.0 g/kg and one animal at 2.5 g/kg. Slight to moderate erythema and edema was also observed in all animals.

Hence, the LD50 value was considered to be 3.0 g/kg, with 95% confidence limits of 1.94–4.06 g/kg, when Groups of four rabbits were treated with the given test chemical by dermal application.

 

Another study mentioned in publications, authoritative database and secondary report was carried out to determine the acute dermal toxicity dose by using the given test chemical in 10 mice at the dose concentration of 10000 mg/kg bw. Animals were observed for mortality. No mortality was observed at10000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be >10000 mg/kg bw, when 10 mice were treated with the given test chemical by dermal application.

 

All the above studies are further supported with the data available in publications, authoritative databases and different handbooks for the given test chemical. The acute dermal toxicity study was conducted in rats at the dose concentration of 3200 mg/kg bw. 50% mortality was observed at 3200 mg/kg bw. Hence, the LD50 value was considered to be 3200 mg/kg bw, when rats were treated with the given test chemical by dermal application.

 

Thus, based on the above summarised studies for test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

 

Justification for classification or non-classification

Based on the above studies for the test chemical, it can be concluded that LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity and the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this range and value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity and cannot be classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.