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Administrative data

Description of key information

EBTBP was administered as a single dose of 2,000 mg/kg to the clipped skin of 6 albino rabbits. The skin of three of the animals was abraded prior to treatment. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr, any excess test article removed, and the animals observed for 14 days. No animals died during the test. The dermal LD50 was > 2,000 mg/

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
Qualifier:
according to
Guideline:
other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Principles of method if other than guideline:
5 male and 5 female rats administered a single oral dose by gavage in corn oil of 7.5 g/kg, and observed for 14 d.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
Single oral dose of 7.5 g/kg bw
No. of animals per sex per dose:
5 males and 5 female
Control animals:
no
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 7.5 other: gm/kg bw
Based on:
test mat.
Remarks on result:
other: no rats died on test
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EBTBP was not acutely toxic to rats by the oral route.
Executive summary:

One group of 5 male and 5 female Sherman-Wistar rats was administered a single dose of EBTBP by gavage in corn oil at 7,500 mg/kg. The animals were observed for 14 days. No animals died on test. The oral LD50 was > 7,500 mg/kg. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
7 500 mg/kg bw
Quality of whole database:
No lethality or adverse effects were observed after acute oral, dermal and inhalation exposure of the substance at or above the limit doses.

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines.
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
aerodynamic dyameter of particle size = 6.0 microns +- 2.22.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric
Duration of exposure:
1 h
Concentrations:
203 mg/L
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Sex:
male/female
Dose descriptor:
LC0
Effect level:
203 mg/L air
Based on:
test mat.
Exp. duration:
1 h

No rats died on the study.

Dyspnea was observed during the exposure and continued post-exposure (up to 5 days) in a few animals. Mean body weight gain was normal 14 days after exposure. At necropsy, red foci in the lungs of a few rats were observed.

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The 1 hr LC50 was > 203 mg/L.
Executive summary:

One group of 5 male and 5 female albino rats was exposed to EBTBP at a concentration of 203 mg/L for 1 hour. Dyspnea and nasal discharge were the principal signs observed during the exposure. No deaths occurred during treatment or the during the 14 day observation period. The inhalation LC50 was > 203 mg/L for 1 hour. This study was performed according to Good Laboratory Practices.  

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
203 000 mg/m³
Quality of whole database:
One group of 5 male and 5 female albino rats was exposed to EBTBP at a concentration of 203 mg/L for 1 hour. Dyspnea and nasal discharge were the principal signs observed during the exposure. No deaths occurred during treatment or the during the 14 day observation period. The inhalation LC50 was > 203 mg/L for 1 hour. This study was performed according to Good Laboratory Practices.  

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:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.
Qualifier:
according to
Guideline:
other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
Principles of method if other than guideline:
Test material applied to clipped back of rabbits, covered in place for 24 hr and observed for toxicity and mortality for 14 d.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
other: albino rabbits
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hr
Doses:
single dose of 2.0 gm/kg bw
No. of animals per sex per dose:
6 rabbits total
Control animals:
no
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 2 other: gm/kg
Based on:
test mat.
Mortality:
no rabbits died on test
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EBTBP was not acutely toxic when administered dermally to rabbits.
Executive summary:

EBTBP was administered as a single dose of 2,000 mg/kg to the clipped skin of 6 albino rabbits. The skin of three of the animals was abraded prior to treatment. The test site was wrapped with an impervious material. The wrapping was removed at 24 hr, any excess test article removed, and the animals observed for 14 days. No animals died during the test. The dermal LD50 was > 2,000 mg/

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Additional information

The substance did not produce any lethality or toxic effects after acute administraion via the oral, dermal or inhalation route at dose levels up to or above the limit dose.


Justification for selection of acute toxicity – oral endpoint
A valid oral toxicity study in rats is available.

Justification for selection of acute toxicity – inhalation endpoint
A valid acute inhalation study in rats is available.

Justification for selection of acute toxicity – dermal endpoint
A valid dermal toxiicty study in rabbits is available

Justification for classification or non-classification

The substance was not acutely toxic following oral, dermal or inhalation exposure. Therefore a classificaiton for acute toxicity is not warranted.