Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because 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 (e.g. skin irritation, skin sensitisation)
Justification for type of information:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
There were no deaths.
No signs of systemic toxicity were noted during the study.
All animals showed expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.

The test material when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.

No corneal or iridial effects were noted during the study.
Minimal conjunctiva 1 irritation was noted in one treated eye one hour after treatment.
All treated eyes appeared normal 24 hours after treatment.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
The study does not need to be conducted because 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 (e.g. skin irritation, skin sensitisation):
Executive summary:

The study does not need to be conducted because 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 (e.g. skin irritation, skin sensitisation):


The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.
There were no deaths.
No signs of systemic toxicity were noted during the study.
All animals showed expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.


The test material when applied as a 20% aqueous dilution produced a primary irritation index of 0.0 and was classified as a NON-IRRITANT to rabbit skin according to the Draize cl assification scheme. No corrosive effects were noted.


No corneal or iridial effects were noted during the study.
Minimal conjunctiva 1 irritation was noted in one treated eye one hour after treatment.
All treated eyes appeared normal 24 hours after treatment.