Registration Dossier

Administrative data

Description of key information

Acute oral toxicity LD50 (male/female): >2000 mg/kg bw (OECD 423, GLP)

Acute dermal toxicity LD50 (male.female): >2000 mg/kg bw (OECD 402, GLP)

Acute inhalation toxicity LC50 (male/female): >1275 mg/L air (OECD 403, GLP)

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:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
other: other guideline: EC Directive 96/54/EC, Part B.1 tris OECD 423, 1996
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
other: Rat, Wistar Crl:(WI)BR
Vehicle:
other: None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Lethargy, hunched posture and/or piloerection were notedamong all animals between days 1 and 7.
Gross pathology:
Effects on organs:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
There is one key study available and it is OECD 423/GLP.

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:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
other: The study was designed to be in compliance with EEC (Annex II, point 5.2.3), OECD 403, US EPA and J-MAFF test guidelines for inhalation studies.
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
other: Albino Sprague-Dawley
Type of inhalation exposure:
other: Snout only
Vehicle:
other: None
Duration of exposure:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 275 mg/L air
Exp. duration:
4 h
Mortality:
Male: CA 1275 mg/L; Number of animals: 5; Number of deaths: 0
Male: 0 mg/L; Number of animals: 5; Number of deaths: 0
Female: CA 1275 mg/L; Number of animals: 5; Number of deaths: 0
Female: 0 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Signs of toxicity related to dose levels: Exagerrated breathing was evident in test rats from 30 minutes into exposure, persisting for at least 2 hours post exposure.
Gross pathology:
Effects on organs:
There were no treatment related findings.
Interpretation of results:
other: Not classified; Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 275 000 mg/m³
Quality of whole database:
There is one key study available and it is OECD 403/GLP.

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:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
other: EC Directive 92/69, B.3 OECD 402, 1987
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
other: Wistar Crl:(WI)BR
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Lethargy, hunched posture, piloerection, chromodacryorrhoea and/or diarrhoea were noted in the majority of animals. The animals had recovered from the symptoms by day 4, with the exception of one female, which showed chromodacryorrhoea between days 13 and 15.
Gross pathology:
Effects on organs:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
Signs of toxicity (local):
Erythema and/or scales were seen in the treated skin-area and/or the right flank of the animals during the observation period.
Interpretation of results:
other: Not classified ; Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
There is one key study available and it is OECD 402/GLP.

Additional information

Oral route

There is one oral toxicity study in rats.

In an acute oral toxicity study (OECD 423/GLP), groups of Wistar Crl:(WI)BR rats (3/sex) were given 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone at a dose of 2000 mg/kg bw. The test substance administered at the doses of 2000 mg/kg did not cause death of any animals. Signs of toxicity related to dose levels were lethargy, hunched posture and/or piloerection noted among all animals between days 1 and 7. No pathologic macroscopic changes were diagnosed during the pathological examination at any dose. The LD50 (males/females) was >2000 mg/kg bw.

Dermal route

There is one dermal toxicity study in rats.

In an acute dermal toxicity study (OECD 402/GLP), groups of Wistar Crl:(WI)BR rats (5/sex) were dermally exposed (semi-occlusive) to 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone at a dose of 2000 mg/kg bw for 24 hours. Signs of toxicity related to dose levels were lethargy, hunched posture, piloerection, chromodacryorrhoea and/or diarrhoea were noted in the majority of animals. The animals had recovered from the symptoms by day 4, with the exception of one female, which showed chromodacryorrhoea between days 13 and 15.  No macroscopic changes were diagnosed during pathological examination. Erythema and/or scales were seen in the treated skin-area and/or the right flank of the animals during the observation period. The LD50 (males/females) was >2000 mg/kg bw.

Inhalation route

There is one inhalation toxicity study in rats.

In an acute inhalation toxicity study (OECD 403/GLP), groups of Albino Sprague-Dawley rats (5/sex) were given 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone (snout only) at a dose of 1275 mg/L air for 4 hours. The time weighted average analysed concentration tested was 98,658 ppm. The test substance administered at the doses of 98,658 ppm did not cause death of any animals. Signs of toxicity related to dose levels were exaggerated breathing evident in test rats from 30 minutes into exposure, persisting for at least 2 hours post exposure. There were no treatment related findings on organs. The LC50 (male/female) was >1275 mg/L air.

The results from these studies are acceptable to use in the human health risk assessment.

Justification for classification or non-classification

Based on the available information in the dossier, the substance 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone (CAS No. 756-13-8) does not need to classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.