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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: discriminating dose = 3942 mg/kg bw

Acute dermal toxicity: no study available

Acute inhalation toxicity: no study available

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)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
One group of five male and five female Wistar rats were dosed at 5.0 ml/kg. The animals were observed for mortality and clinical signs through day 14. The surviving animals were randomly dissected.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
At the start of the study the rats were approx. 9 respective 14 weeks old. The average weight of the male rats was 151 g, and the average weight of the female rats was 159 g.
The rats were kept in Macrolon typ III cages at a temperature of 22 +/- 1.5°C. Air humidity was 60 +/- 5% at artifical light for 12 hours daily. Water was ad libitum.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
About 16 hours before the application and 4 hours afterwards feed was restricted.
Doses:
5 ml/kg bw = 3942 mg/kg bw.
No. of animals per sex per dose:
5 male and 5 female rats per dose
Control animals:
no
Details on study design:
The animals killed at the end of the study were randomly dissected.
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 mL/kg bw
Based on:
test mat.
Remarks on result:
other: 5 ml/kg bw = 3942 mg/kg bw.
Mortality:
No mortality occured.
Clinical signs:
other: No clinical signs were observed.
Gross pathology:
No adverse findings.
Other findings:
No data.
Interpretation of results:
GHS criteria not met
Conclusions:
A single dose of 5 ml/kg bw = 3942 mg/kg bw was tolerated without symptoms.
Executive summary:

One group of five male and five female Wistar rats were dosed at 5.0 ml/kg. The animals were observed for mortality, and clinical signs through day 14. The surviving animals were randomly dissected. A single dose of 5 ml/kg bw = 3942 mg/kg bw was tolerated without symptoms. No mortality occured.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
3 942 mg/kg bw
Quality of whole database:
Scientifically acceptable and well documented.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

Justification for classification or non-classification

In the acute oral toxicity study a single dose of 5 ml/kg bw = 3942 mg/kg bw was tolerated without symptoms. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.

No studies were available for acute dermal and acute inhalation toxicity. According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms to the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.