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Description of key information

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:
Shortly after administration, the material began to leak from the rectum. Transient sluggishness was reported.
Body weight:
Not 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

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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

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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 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:
No evidence
Body weight:
no data
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.