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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
Type of information:
other: extrapolation from results obtained by the oral route
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
Cross-reference
Reason / purpose for cross-reference:
reference to other study
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish 1) is available.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across approach from experimental data (study according to OECD 423 and GLP) on an analogue substance.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 490 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on a read-across from an analogue substance.
Interpretation of results:
other: Not classified based on CLP criteria.
Conclusions:
Based on read-across approach from analogue substance P0310, the LD50 of the substance P-1057 is calculated to be greater than 2490 mg/kg bw.
Executive summary:

Based on experimental results obtained in a study according to OECD 423 on analogue substance P0310 where the LD50 for female rats was determined to be greater than 2000 mg/kg bw, the read-across approach is applied and the LD50 for the substance P-1057 is determined to be greater than 2490 mg/kg bw.

Data source

Reference
Reference Type:
other: extrapolation
Title:
Unnamed
Year:
2011

Materials and methods

Principles of method if other than guideline:
Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
Test type:
other: extrapolation

Test material

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 12.45 mg/L air
Based on:
test mat.
Exp. duration:
4 h

Any other information on results incl. tables

Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the inhalation route.

From the read-across approach, it is concluded that the oral LD50 for the substance is greater than 2490 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.

Based on this acute oral toxicity data, an oral NOAEL may be identified as greater than 2490 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of 2490 mg/kg bw is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 12450 mg/m3 (12.45 mg/l). Therefore, the 4 -h LC50 would be greater than 12.45 mg/l (dust/particles inhalation).

Applicant's summary and conclusion

Interpretation of results:
other: Not classified based on CLP criteria.
Conclusions:
Based on the assumptions for the extrapolation from the acute oral toxicity data, the inhalation 4-h LC50 would be greater than 12.45 mg/l.
Executive summary:

Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the inhalation route.

From the read-across approach, it is concluded that the oral LD50 for the substance is greater than 2490 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.

Based on this acute oral toxicity data, an oral NOAEL may be identified as greater than 2490 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of 2490 mg/kg bw is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 12450 mg/m3 (12.45 mg/l). Therefore, the 4 -h LC50 would be greater than 12.45 mg/l (dust/particles inhalation).