Hyoscine

Endpoint summary

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

Reference

Reference 1

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:

other: other: 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.

Reference 2

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.