Acetic acid, C11-14-isoalkyl esters, C13-rich

Endpoint summary

Description of key information

In the key acute oral toxicity study in rats, conducted according to a protocol similar to OECD TG 401 and in compliance with GLP, the reported LD50 value was greater than 5000 mg/kg bw (Biosearch, 1979).

In the key acute dermal toxicity study in rats, conducted according to a protocol similar to OECD TG 402 and in compliance with GLP, the reported LD50 value was greater than 2000 mg/kg bw (Biosearch, 1979).

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

Study period:

10 July 1979 to 24 July 1979

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: the test substance was administered undiluted


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no data
- Preliminary purification step (if any): no data

Species:

rat

Strain:

Sherman

Remarks:

Sherman-Wistar strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: no data
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 24 hours prior to treatment the animals were deprived of food only.
- Housing: no data
- Diet: food was available, ad libitum.
- Water: water was available, 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

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: Dose volume not specified.

Doses:

5.0 g/kg bw(5000 mg/kg)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each rat was weighed prior to administration and at the end of the study period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not used.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

other: There were no unusual clinical signs of toxicity noted.

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Other findings:

No other findings were noted. No unusual behavioural changes were noted.

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study, conducted according to a protocol similar to OECD TG 401 and in compliance with GLP, the reported LD50 value was greater than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 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:

key study

Study period:

10 July 1979 to 24 July 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test material was applied to abraded skin, under occlusive dressing.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no data
- Preliminary purification step (if any): no data
- Final dilution of a dissolved solid, stock liquid or gel: the test substance was applied undiluted

Species:

rabbit

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 2.0 and 3.0 kg
- Fasting period before study: no data
- Housing: no data
- Diet: no data
- Water: no data
- 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back (abraded)
- % coverage: no data
- Type of wrap if used: The treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any excess material was removed and the approximate amount remaining was noted.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2.0 g/kg bw (2000 mg/kg bw)

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were weighed prior to dosing and at the end of the study period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not used

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

other: No unusual clinical or behavioural signs of toxicity were noted

Gross pathology:

Gross pathologic examinations revealed nothing remarkable.

Other findings:

No other findings were noted.

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study, conducted according to a protocol similar to OECD TG 402 and in compliance with GLP, the reported LD50 value was greater than 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

In the key acute oral toxicity study, conducted according to a protocol similar to OECD TG 401 and in compliance with GLP, the reported LD50 value was greater than 5000 mg/kg bw (Biosearch, 1979).

Following oral gavage administration of 5000 mg/kg bw undiluted test substance (Acetic acid, C11-14-isoalkyl esters, C13-rich) to 5 male and 5 female albino rats, all animals survived throughout the 14 -day observation period. No clinical signs of toxicity were noted in any of the test animals. The expected body weight gain was observed in all of the test animals. No macroscopic abnormalities were observed in any of the test animals at necropsy.

In the key acute dermal toxicity study, conducted according to a protocol similar to OECD TG 402 and in compliance with GLP, the reported LD50 value was greater than 2000 mg/kg bw (Biosearch, 1979).

Following a 24-hour occluded topical application of 2000 mg/kg bw undiluted test material (Acetic acid, C11-14-isoalkyl esters, C13-rich) onto the abraded skin of the back of 3 male and 3 female albino rabbits, all animals survived throughout the 14-day observation period. No clinical signs of toxicity were noted in any of the test animals. The expected body weight gain was observed in all of the test animals. No macroscopic abnormalities were observed in any of the test animals at necropsy.

Justification for classification or non-classification

Based on the available data for Acetic acid, C11-14-isoalkyl esters, C13-rich, no classification is required for acute oral or dermal toxicity according to Regulation (EC) No. 1272/2008.