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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Description of key information

RA to OECD 422: NOAEL for maternal systemic toxicity (42 d, oral, rat) = 200 mg/kg bw/d

RA to OECD 422: NOEL for reproductive performance (42 d, oral, rat) = 1000 mg/kg bw/d

RA to OECD 422: NOEL (systemic toxicity) for F1 -generation (42 d, oral, rat) = 1000 mg/kg bw/d

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
For this endpoint a read across was performed to a chemical similar compound that is also found after F6-Chloride degradation in aquous environment and under physiological conditions. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 422. A read across justification withb degradation pathway is provided in chapter 13 of this dossier.
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Remarks:
systemic toxicity
Effect level:
200 mg/kg bw/day (actual dose received)
Based on:
other: structural anlogue substance
Sex:
male/female
Basis for effect level:
food consumption and compound intake
histopathology: non-neoplastic
Remarks on result:
other: pH adjsutment required
Key result
Dose descriptor:
NOEL
Remarks:
reproductive performance
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: structural analogue substance
Sex:
male/female
Basis for effect level:
other: no effects on reproductive performance were observed
Key result
Critical effects observed:
no
Lowest effective dose / conc.:
1 000 mg/kg bw/day (actual dose received)
System:
gastrointestinal tract
Organ:
stomach
Key result
Dose descriptor:
NOEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: strutural analogue substance
Sex:
male/female
Basis for effect level:
other: no effects were observed
Remarks on result:
other: pH must be adjusted
Key result
Critical effects observed:
no
Key result
Reproductive effects observed:
no
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Guideline and GLP conform study
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

For developmental toxicity no effects have been observed up to the highest dose of 1000 mg/kg bw/d.

RA to OECD 422: NOEL for maternal developmental toxicity (42 d, oral, rat) = 1000 mg/kg bw/d

RA to OECD 422: NOEL (developmental toxicity) for F1 -generation (42 d, oral, rat) = 1000 mg/kg bw/d

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
For this endpoint a read across was performed to a chemical similar compound that is also found after F6-Chloride degradation in aquous environment and under physiological conditions. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 422. A read across justification withb degradation pathway is provided in chapter 13 of this dossier.
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Remarks:
sytemic toxicity
Effect level:
200 mg/kg bw/day (actual dose received)
Based on:
other: structural analogue substance
Basis for effect level:
food consumption and compound intake
histopathology: non-neoplastic
Remarks on result:
other: pH must be adjusted
Key result
Dose descriptor:
NOEL
Remarks:
maternal developmental toxicity
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: structural anlogue substance
Basis for effect level:
other: no effects were observed
Key result
Abnormalities:
no effects observed
Key result
Dose descriptor:
NOEL
Remarks:
developmental toxicity
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
other: structural analogue substance
Sex:
male/female
Basis for effect level:
other: no effects were observed
Remarks on result:
other: pH must be adjusted
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
GLP and Guideline conform study
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the data provided, the test item is not considered to be classified for reproductive toxicity after oral expsoure according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776.

Additional information