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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 (EU Method B.1): LD50 >2000 mg/kg bw

Acute dermal (EU Method): LD50 >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:
No data available, ECHA provided study summaries migrated from the SNIF format.
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: Annex V, B1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: Rat (Sprague-Dawley)
Vehicle:
other: None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: No signs of systemic toxicity were noted during the study period. All animals showed gains in bodyweight over the study period.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy of animals killed at
the end of the study period.
Interpretation of results:
other: Not classified
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
In an acute oral toxicity study with male and female rats, performed according to EU Method B.1 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.
Executive summary:

RB68 was tested in an acute oral toxicity study with male and female rats, performed according to EU Method B.1 test guideline and GLP principles.

No mortality occurred. No signs of systemic toxicity were noted during the study period. All animals showed gains in bodyweight over the study period.

No abnormalities were found at macroscopic post mortem examination of the animals. Based on the results, an LD50 >2000 mg/kg bw was determined. RB68 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The study has klimisch code 1.

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:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
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:
No data available, ECHA provided study summaries migrated from the SNIF format.
Reliability:
2 (reliable with restrictions)
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
yes
Species:
other: Rat (Sprague-Dawley)
Type of coverage:
semiocclusive
Vehicle:
other: Liquid test material was applied as supplied.
Duration of exposure:
24 h
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: No signs of systemic toxicity were noted during the study.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy.
Other findings:
Signs of toxicity (local):
No signs of skin irritation were noted during the study.
Interpretation of results:
other: Not classified.
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
In an acute dermal toxicity study with rats, performed according to an EU Method and GLP principles, an LD50 >2000 mg/kg bw was determined.
Executive summary:

RB68 was tested in an acute dermal toxicity study with male and female rats, performed according to an EU Method and GLP principles.

No mortality occurred. No signs of systemic toxicity and no signs of skin irritation were noted during the study. No abnormalities were found at macroscopic post mortem examination of the animals.

Based on the results, an LD50 >2000 mg/kg bw was determined. RB68 does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The study has klimisch code 1.

Additional information

Acute oral:

RB68 was tested in an acute oral toxicity study with male and female rats, performed according to EU Method B.1 test guideline and GLP principles.

No mortality occurred. No signs of systemic toxicity were noted during the study period. All animals showed gains in bodyweight over the study period.

No abnormalities were found at macroscopic post mortem examination of the animals. Based on the results, an LD50 >2000 mg/kg bw was determined.

Acute dermal:

RB68 was tested in an acute dermal toxicity study with male and female rats, performed according to an EU Method and GLP principles.

No mortality occurred. No signs of systemic toxicity and no signs of skin irritation were noted during the study. No abnormalities were found at macroscopic post mortem examination of the animals.

Based on the results, an LD50 >2000 mg/kg bw was determined.

Justification for classification or non-classification

Based on the above study results, RB68 does not have to be classified and has no obligatory labelling requirement for acute oral, acute dermal and acute inhalation toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).