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Administrative data

Description of key information

The acute dermal and oral toxicity of the test substance MBTS is very low, indicated by LD50 values greater than 7940 mg/kg bw. The acute oral LD50 value in rats is greater than 7940 mg/kg bw (Monsanto Co. 1973) and the dermal LD50 value in rabbits is greater than 7940 mg/kg bw (Monsanto Co. 1973).

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles
Principles of method if other than guideline:
Acute oral toxicity study
GLP compliance:
no
Test type:
other: acute oral toxicity study
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2160, 5010, 7940 mg/kg bw
No. of animals per sex per dose:
1 to 5 animals per dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality, clinical signs: reduced appetite and activity one to three days

Mortality: no mortality occurred during the study

3160 mg/kg: male -, female (0/1), combinded (0/1)

5010 mg/kg: male (0/1), female - , combinded (0/1)

7940 mg/kg: male (0/2), female (0/3), combinded (0/5)

Clinical signs:

Reduced appetite and activity (one to three days)

Gross autopsy

Survivors (7 day): viscera appeared normal

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 940 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles
Principles of method if other than guideline:
other: acute dermal toxicity study
GLP compliance:
no
Test type:
other: acute dermal toxicity study
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
corn oil
Duration of exposure:
24 h
Doses:
5010, 7940 mg/kg bw
No. of animals per sex per dose:
1 to 2 animal per dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Based on:
test mat.
Remarks on result:
other: clinical signs: reduced appetite and activity one two days

Mortality: no death occurred during the study

5010 mg/kg: male 0/1, female -, combined 0/1

7940 mg/kg: male 0/1, female 0/1, combined 0/2

Clinical signs observed: reduced appetite and activity (one to two days)

Gross autopsy (survivors 14 days study termination): viscera appeared normal

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 940 mg/kg bw

Additional information

Acute toxicity: oral

The acute oral toxicity of MBTS was evaluated in acute oral toxicity studies in rats. Although the study results are reliable the test design of the studies does not comply with the current guidelines.

In an acceptable documented study with Sprague-Dawley Albino rats a 25% suspension in corn oil of the test substance was administered by gavage to male and female rats at doses of 3160, 5010 and 7940mg/kg bw. A 7-day observation period followed administration. No mortality occurred during the study. An oral LD50 value > 7940 mg/kg bw was suggested. Clinical signs were observed and included reduced appetite and activity (one to three days). Autopsy was performed at study termination; viscera of all animals appeared normal at sacrifice (Monsanto Co. 1973).

In a limited documented acute toxicity study with Sprague-Dawley rats, an oral LD50 value greater 10000 mg/kg bw is suggested (Monsanto Co. 1972).

Acute toxicity: dermal

The acute dermal toxicity of MBTS was evaluated in a limited but acceptable documented acute dermal toxicity study with New Zealand Albino rabbits (Monsanto Co. 1973). One male was treated with 5010 mg/kg bw and one male and one female with 7940 mg/kg bw MBTS (40% test substance suspension in corn oil) for 24 hours. No mortality occurred during the study. Clinical signs observed included reduced appetite and activity (one to two days). Gross autopsy at study termination (14 days after test substance application) revealed no abnormalities in viscera in the treated animals. A dermal LD50 value greater than 7940 mg/kg bw is suggested.

Justification for classification or non-classification

The acute dermal and oral toxicity of the test substance MBTS is very low, indicated by LD50 values greater than 7940 mg/kg bw. No classification for the endpoints oral and dermal acute toxicity is required according to the classification criteria of regulation no. 1272/2008 (GHS).

Note: according to regulation no. 1272/2008 (GHS) (EUH031: contact with acids liberates toxic gas).