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Administrative data

Description of key information

In an acute oral toxicity study the substance was administered to Wistar rats (3 animals/sex) by gavage at a dose level of 2000 mg/kg bw (single administration). There were no effects on mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities were found at macroscopic post-mortem examination. The oral LD50 is 2000 mg/kg bw. In an acute dermal toxicity study the substance was administered to Wistar rats (5 animals/sex) by dermal application at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination.The dermal LD50 is over 2000 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:
key study
Study period:
14 June 2016 to 12 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Deviations from the maximum level of daily mean relative humidity occurred. The study integrity was not adversely affected by the deviation.
Deviations:
yes
Remarks:
Deviations from the maximum level of daily mean relative humidity occurred. The study integrity was not adversely affected by the deviation.
GLP compliance:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Three animals
Control animals:
not specified
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were noted.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be normal.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
No findings noted.
Interpretation of results:
other: EU classification criteria not met
Conclusions:
The oral LD50 of the sunstance in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

In an acute toxicity study the substance was administered to Wistar rats (3 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to address requirements.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Sufficient to meet requirement.

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:
23 September 2016 - 11 October 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Deviations from the minimum level of daily mean relative humidity occurred. The study integrity was not adversely affected by the deviation.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Purity: 99.56%
Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han) (outbred, SPF-Quality)
Sex:
male/female
Details on test animals and environmental conditions:
Young adult animals (approx. 10 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean. Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw (single dose on Day 1)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Not classified and has no obligatory labelling requirement for acute dermal toxicity according to GHS.
Mortality:
No mortality occurred.
Clinical signs:
Lethargy, chromodacryorrhoea of the snout, ptosis, flat posture, restless behaviour and/or piloerection were noted for all animals on Days 1 and/or 2. General erythema of the treated skin was noted for two male animals on Day 2 only.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 value of the susbtance in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, the substance does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to GHS.
Executive summary:

In an acute dermal toxicity study the substance was administered to Wistar rats (5 animals/sex) by dermal application at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination.The dermal LD50 of the susbtance in Wistar rats was established to exceed 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to meet requirement.

Additional information

Justification for classification or non-classification

Based on the findings of reliable acute toxicity studies via the oral and dermal routes of exposure conducted on the substance, classification of the substance is not justified.