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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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:
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.