Registration Dossier

Diss Factsheets

Administrative data

Description of key information

WoE approach based on Klimish 4 _1 page study summary :

- Acute Oral toxicity in rats on Rhodial abstract_ dated on 1977_LD50 (Oral) >5000 mg/Kg bw

- Acute Dermal toxicity in rabbits on Rhodial abstract_ dated on 1977_LD50 (dermal) >5000 mg/Kg bw

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:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Remarks:
1 page summary
Qualifier:
according to guideline
Guideline:
other: no guideline specified on the 1 page study summary
GLP compliance:
no
Remarks:
Conducted prior to the GLP guidelines
Limit test:
yes
Specific details on test material used for the study:
Sample marking: 77-413, Rhodial
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5'000 mg/Kg BW
No. of animals per sex per dose:
1 dose per animals
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred
Other findings:
Tox signs: Slight lethargy , chromorhinorrhea
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of SILVIAL in rat has been determined to be above 5'000 mg/Kg bw. Hence the GHS criteria are not met for classification.
Executive summary:

The LD50 of SILVIAL in rat has been determined to be above 5'000 mg/Kg bw. Hence the GHS criteria are not met for classification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Remarks:
1 page study summary
Qualifier:
according to guideline
Guideline:
other: no guideline specified on the 1 page study summary
GLP compliance:
no
Remarks:
Conducted prior to the GLP guidelines
Limit test:
yes
Specific details on test material used for the study:
Sample marking: 77-413, Rhodial
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Doses:
5'000 mg/Kg BW
No. of animals per sex per dose:
1 dose per animals
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 death occurred on day 1
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of Silvial in rabbits has been determined to be above 5'000 mg/Kg bw. Hence the GHS criteria are not met for classification.
Executive summary:

The LD50 of Silvial in rabbits has been determined to be above 5'000 mg/Kg bw. Hence the GHS criteria are not met for classification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Justification for classification or non-classification

The LD50 (oral and dermal) of SILVIAL in rats and rabbits have been determined to be both above 5'000 mg/Kg bw. Hence the GHS criteria are not met for classification.