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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only data summary seen from SNIF docs
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
Single dose 5000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Preliminary study:
not classified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Conclusions:
Data obtained through ECHA Inquiry under the 12 year rule.
Executive summary:

Data obtained through ECHA Inquiry under the 12 year rule.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only data summary seen from SNIF docs
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Principles of method if other than guideline:
other guideline: method B3
GLP compliance:
yes
Preliminary study:
Comments:
4103 PERCUT LD50: >2000 mg/kg
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Conclusions:
Data obtained through ECHA Inquiry under the 12 year rule.
Executive summary:

Data obtained through ECHA Inquiry under the 12 year rule.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

Justification for classification or non-classification