Registration Dossier

Administrative data

Description of key information

According to CLP Regulation Annex VI scopolamine is harmonised classified as acute oral toxic category 2 (H300), acute dermal toxic category 1 (H310) and acute inhalation toxic category 2 (H330).

Based on the available data no further investigations are necessary.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
24 March 1961
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Experimental design according to Everett (1956).
GLP compliance:
no
Limit test:
no
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
not specified
No. of animals per sex per dose:
25
Control animals:
other: not required as Scopolomanine was used as one reference substance
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 275 mg/kg bw
Based on:
test mat.
Clinical signs:
effective dose (salivation, 50% of test animals): 0.09 mg/kg bw effective dose (tremor, 50% of test animals): 0.14 mg/kg bw
Interpretation of results:
study cannot be used for classification
Conclusions:
A LD50 value of 1275 mg/kg bw in mice was reported in a publication. As the report is not sufficiently documented the reliability is not assignable.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1991
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
Experimental measurement (data is taken from a secondary source, information about the methodology is not available).
GLP compliance:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 650 mg/kg bw
Based on:
test mat.
Interpretation of results:
study cannot be used for classification
Conclusions:
A LD50 value of 2650 mg/kg bw was reported in secondary literature (handbook). As the secondary literature is not sufficiently documented the reliability is not assignable.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose for cross-reference:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

According to CLP Regulation Annex VI scopolamine is harmonized classified as acute oral toxic category 2 (H300), acute dermal toxic category 1 (H310) and acute inhalation toxic category 2 (H330).

Two LD 50 values for acute toxicity via the oral route are available for Scopolamine, 1275 mg/kg bw in mice (Frommel, 1961) and 2650 mg/kg bw in rats (Handbook, 1961). The values show an indication for comparable toxicity using different species (mice, rats). Neither of these studies is considered relevant for the acute human toxicity evaluation. Given the agreed harmonized classification of the substance and the corresponding high hazard and considering animal welfare, no further studies for acute oral toxicity have been conducted.

No acute toxicity study via the dermal route is available, however, a harmonized classification as Cat.1 H310 has been agreed upon. Hence any further studies are not needed for this endpoint.

No acute toxicity study via the inhalation route is available, however, a harmonized classification as Cat.2 H330 has been agreed upon. Hence any further studies are not needed for this endpoint.

 





Justification for classification or non-classification

According to CLP Regulation Annex VI scopolamine is classified as acute oral toxic cat. 2 (H300), acute dermal toxic cat. 1 (H310) and acute inhalation toxic cat. 2 (H330).

The same classification has been adopted as "self classification" for acute endpoints.