Tributyl O-acetylcitrate

Endpoint summary

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:

1959

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Older study: meets scientific standards with acceptable restrictions (limited number of animals in study, partly limited documentation)

Qualifier:

no guideline available

Guideline:

other: Study from 1959 (no guidelines available at the time the study was performed)

Deviations:

not applicable

GLP compliance:

no

Remarks:

Study from 1959 (GLP was not compulsory at the time the study was performed)

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

Single dosing with 10 - 30 mL/kg (ca. 10.5 - 31.5 g)

No. of animals per sex per dose:

Dosed was a group of 5 animals (no further details reported)

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 21 d
Frequency of observations and weighing: not reported
Necropsy of survivors performed: not reported
Other examinations performed: body weight,organ weights, histopathology

Statistics:

Not further specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 31 500 mg/kg bw

Remarks on result:

other: Endpoint was estimated, as there were no signs of toxicity to be found at test doses

Mortality:

No deaths occured at any dose level throughout the study.

Clinical signs:

other: Shortly after administration, the material began to leak from the rectum. Transient sluggishness was reported.

Gross pathology:

Not reported

Interpretation of results:

Toxicity Category V

Remarks:

Migrated information

Conclusions:

In this older study with Wistar rats the LD50 was estimated with > 30 mL/kg (ca. 31500 mg/kg)

Executive summary:

In this older study Wistar rats were dosed once with 10 - 30 mL/kg (ca. 10500 - 31500 mg/kg) via gavage. All animals were observed for signs of toxicity for 21 d following dosing. The dosing caused no deaths and the estimated LD50 was given with > 30 mL/kg (ca. 31500 mg/kg).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

31 500 mg/kg bw

Quality of whole database:

There are a lot of data available for the toxicological profile of ATBC.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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:

presumably 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Methodical details are missing

Qualifier:

no guideline followed

Principles of method if other than guideline:

3 male albino rabbits were used. The abdomen was closely clipped and 1 mL/kg bw was placed on the intact skin daily for 4 days. The animals were observed daily and for a period of 36 h after the last application.

GLP compliance:

not specified

Test type:

other: Data from a dermal skin irritation study are used, as 1 mL/kg bw (ca. 1000 mg/kg) was administered to rabbits

Limit test:

no

Species:

rabbit

Strain:

other: Albino

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
abdomen (intact skin)

Duration of exposure:

daily for 4 days

Doses:

1 mL/kg bw (ca. 1000 mg)

No. of animals per sex per dose:

3 m

Control animals:

no

Details on study design:

The abdomen was closely clipped and 1 mL/kg bw was placed on the intact skin daily for 4 days. The animals were observed daily and for a period of 36 h after the last application.

Statistics:

no data

Sex:

male

Dose descriptor:

approximate LD50

Effect level:

> 1 000 mg/kg bw

Mortality:

No evidence

Clinical signs:

other: No evidence

Gross pathology:

no data

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

ATBC did not induce toxic signs when applied to 3 rabbits over 4 consecutive days.

Executive summary:

In a skin irritation study, which likewise could be used as acute dermal toxicity study (ATBC was applied to rabbits over 4 days at a dosage of 1 mL/kg bw/d; ca. 1000 mg/kg), no signs of toxicity were noted. Therefore it can be concluded that ATBC is not toxic after dermal administration to rabbits at a daily dermal dose of ca. 1000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Quality of whole database:

good quality

Additional information

There are no studies available performed according to current guidelines.

Oral:

In rats dosed with 10 to 30 mL/kg (ca. 10500 - 31500 mg/kg) no deaths occurred at any dose level throughout the study (post-observation period: 21 d) (Finkelstein & Gold, 1959; Gold et al., 1959). Therefore, an oral LD50 value of > 31500 mg/kg can be assumed.

Dermal:

There are no studies available. However, for this route there is a very low potential for toxicity due to a very high oral LD50 and also it is unlikely that ATBC is absorbed efficiently through the skin. In addition data from a skin irritation study, which likewise could be used as acute dermal toxicity study (ATBC was applied to rabbits over 4 days at a dosage of 1 mL/kg bw/d; ca. 1000 mg/kg), no signs of toxicity were noted. Therefore it can be concluded that ATBC has a very low potential concerning dermal toxicity.

Inhalation:

There are no studies available. ATBC is predicted to present a very low potential for toxicity via inhalation due to the low vapour pressure and a very high oral LD50.

Justification for selection of acute toxicity – oral endpoint
Acceptable well documented publication which meets basic scientific principles.

Justification for selection of acute toxicity – inhalation endpoint
Inhalation is not the relevant route of exposure, oral and dermal route are the main routes of possible exposure.

Justification for selection of acute toxicity – dermal endpoint
Acceptable well documented publication which meets basic scientific principles.

Justification for classification or non-classification

Based on the available data there is no need to classify ATBC as acute toxic after oral, dermal or inhalative exposure.