Registration Dossier

Administrative data

Description of key information

HQEE is of low acute toxicity in mammals by both the oral and dermal routes.

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)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
However was subject to Quality Assurance
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: 0.5% aqueous guar gum
Doses:
5000mg/kg
No. of animals per sex per dose:
5 males and 5 females
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None observed
Body weight:
All animals gained weight normally
Gross pathology:
No treatment related changes observed
Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
The oral oral LD50 >5000 mg/kg to rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Sufficient to meet data requirements.
Justification for selection of acute toxicity – oral endpoint: Only one study available. The study is Klimisch 2.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
An acute inhalation toxicity study is scientifically unjustified and is not in the interests of animal welfare. Acute studies are available by the oral and dermal routes.

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)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
However was subject to Quality Assurance
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
Solid moistened with water
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
None
Clinical signs:
None observed




Body weight:
All animals gained weight normally
Gross pathology:
No treatment related changes observed
Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
The dermal LD50 >2000 mg/kg to rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to meet data requirements.
Justification for selection of acute toxicity – dermal endpoint: Only one study available. The study is Klimisch 2.

Additional information

HQEE is of low acute toxicity in mammals by both the oral and dermal routes.The acute oral LD50 is > 5000 mg/kg while the acute dermal LD50 is > 2000 mg/kg. Testing by the inhalation route is not scientifically justified.




Justification for classification or non-classification

Given the available LD50 values, HQEE does not meet the criteria for classification for acute toxicity by either the oral or dermal routes.