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Description of key information

Acute Inhalation Toxicity: LC50=>2833400 mg/m³ (OECD 403; GLP)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study.
Qualifier:
according to guideline
Guideline:
other: OECD Guideline No 403, Acute Inhalation Toxicity, May 1981.
GLP compliance:
yes
Limit test:
no
Species:
other: Rat, Crl:CD BR
Vehicle:
other: compressed air
Details on inhalation exposure:
Whole body exposure
Duration of exposure:
4 h
Dose descriptor:
LC50
Effect level:
> 457 000 ppm
Exp. duration:
4 h
Clinical signs:
other: Signs of toxicity related to dose levels: During the exposure, hyperactivity and then prostration were noted for all animals. At the one-hour post-exposure observation, there were no toxicological significant signs noted. All animals appeared normal on da
Gross pathology:
Effects on organs:
Four animals (1M,3F) had dark red lungs noted at necropsy.
Two females had cysts on the kidneys and one female had an enlarged pituitary gland. There were no other findings at the schedulded necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
2 833 400 mg/m³
Quality of whole database:
Information from migrated NONS file, as per inquiry number 06-2120010181-80-0000, permission to refer granted by ECHA.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Toxicty: Inhalation

One acute inhalation toxicity study in the rat was available. In the key study (OECD 403, GLP), there were no mortalities. Two animals exhibited slight body weight loss from day 0 to day 3 (less the 4% of day 0 weight). Four animals (1M, 3F) had dark red lungs noted at necropsy. Two females had cysts on the kidneys and one female had an enlarged pituitary gland.

As no deaths were observed, the LC50 value for the acute inhalation toxicity endpoint is > 457000 ppm (2833400 mg/m3).

Justification for selection of acute toxicity – oral endpoint

In accordance with Column 2 of Annex VII Section 8.5.1, the study is not required for gases if a study on acute toxicity by the inhalation route is available.

Justification for selection of acute toxicity – inhalation endpoint

Only 1 key study available.

Justification for selection of acute toxicity – dermal endpoint

In accordance with Column 2 of Annex VIII Section 8.5, as there  is only 1 route of exposure (inhalation), information for only that route need be provided.

Justification for classification or non-classification

Based on the available information in the dossier, the substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.