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Administrative data

Description of key information

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
other: polyethylene glycol
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
No clinical signs
Body weight:
no effects on weight gain
Gross pathology:
no findings
Other findings:
none

Dose (mg/kg bw) Toxicological results  Onset and duration of signs  Onset of mortality
(1st) 2000 0 / 0/ 3 --- --- 
(2nd) 2000 0 / 0/ 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs after treatment / number of animals treated

Executive summary:

The LD50 cut-off value is > 5000 mg/kg bw based on the result of a study performed according to OECD TG 423. The test dose of 2000 mg/kg was tolerated without any findings.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 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:
key study
Study period:
September 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
other: acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Statistics:
none: limit test
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no clinical signs, no effects on weight development and gross pathological findings
Mortality:
none
Clinical signs:
none
Body weight:
not influenced by treatment
Gross pathology:
no noticable gross pathological findings
Executive summary:

An acute dermal toxicity study was performed according to OECD TG 402. 2000 mg/kg of the test item was applied semiocclusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and no gross pathological findings were observed during the 14 -days observation period. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute toxicity: oral

The LD50 cut-off value is > 5000 mg/kg bw based on the result of a study performed according to OECD TG 423. The test dose of 2000 mg/kg was tolerated without any findings. Acute toxicity: InhalationNo data available Acute toxicity: dermal

An acute dermal toxicity study was performed according to OECD TG 402. 2000 mg/kg of the test item was applied semiocclusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and no gross pathological findings were observed during the 14 -days observation period. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Acute toxicity: oral

The LD50 cut-off value is > 5000 mg/kg bw. (rat, female)

No classification required according to EU-Directive 67/548/EEC, Annex VI.

No classification required according to Regulation (EC) No 1272/2008, Annex I.

Acute toxicity: inhalation

No data available

No classification required according to EU-Directive 67/548/EEC, Annex VI.

No classification required according to Regulation (EC) No 1272/2008, Annex I.

Acute toxicity: dermal

The LD50 -value is > 2000 mg/kg bw (rat, male/female)

No classification required according to EU-Directive 67/548/EEC, Annex VI.

No classification required according to Regulation (EC) No 1272/2008, Annex I.