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Diss Factsheets

Administrative data

Description of key information

Oral: LD50 Males: 50 -300 mg/kg bw for rat
Dermal: LD50 Males: > 2000 mg/kg bw for rat
Inhalation: LC50 Males: > 0.5 - < 2.0 mg/L for rat

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
Study period:
2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EC No 440/2008 Part B. Acute Oral Toxicity, Acute Toxic Class Method
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF), November 2000, including the most recent revisions
Version / remarks:
November 2000
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
other: Wistar Han
Sex:
male
Details on test animals or test system and environmental conditions:
based on previous test results (Ac. Oral tox. 1981 ROND) male rats were known to be significantly more sensitive than females
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
50 and 300 mg/kg bw
No. of animals per sex per dose:
3 males
Control animals:
no
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 50 - <= 300 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50 cut-off
Effect level:
200 mg/kg bw
Based on:
test mat.
Mortality:
50 mg/kg bw: all 3 animals survived
300 mg/kg bw: all animals were found dead or sacrified in moribound condition between day 2 and 4 after treatment
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
200 mg/kg bw

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
Study period:
2019-2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
September 2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EC No 440/2008, part B. Acute Toxicity (inhalation), May 2008, amended by COMMISSION REGULATION (EU) No 260/2014
Version / remarks:
24 January 2014
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
Version / remarks:
November 2000
Deviations:
no
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes
Species:
rat
Strain:
other: Wistar Han
Sex:
male/female
Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
4.9.2. Test Atmosphere Concentration Sampling
A total of 6 and 8 representative samples were taken for determination of the actual
concentration during exposure at 2 and 0.5 mg/L, respectively. Samples were drawn from the
test atmosphere through a tube mounted in one of the free animal ports of the exposure
chamber. Sample volumes were measured by means of a dry gas meter (type G 1.6, Actaris
Meterfabriek B.V., Dordrecht, The Netherlands). The samples were drawn through series of
four impingers (2 mg/L) and four or two impingers (0.5 mg/L) filled with acetonitrile as
collection fluid. The amount of test item collected was measured analytically (analytical
method developed under test facility project number 20184667). Subsequently the timeweighted mean concentrations with the standard deviations were calculated.
At 2 mg/L, only the first two impinger samples were used for calculation as from sample 3
onwards the third and fourth impingers showed high values. Normally, these impinger
samples should be negligibly small and it was concluded that a mistake was made at sample 3
which contaminated the impingers at the subsequent measurements. Sample 3 was excluded
as the concentration was unrealistically high as no changes were made for the generation
settings. Inclusion of the sample would lead to an actual concentration exceeding the amount
of test item used (nominal concentration).
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
Initially, 3-PENTENENITRILE was administered as a vapor by nose only inhalation for
4 hours to one group of five male and five female Wistar Han rats at a target concentration of
2 mg/L. Based on the results, the males were identified as most sensitive sex and therefore
five males were exposed at a target concentration of 0.5 mg/L.
No. of animals per sex per dose:
2 mg/L: 5 male and 5 female rats
0.5 mg/L: 5 male rats
Control animals:
no
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.5 - <= 2 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
males 0.5 mg/L: 0
males 2.0 mg/L: 4
females 2.0 mg/L: 1
Body weight:
No abnormalities
Gross pathology:
At 2 mg/L, macroscopic post mortem examination revealed no test item related abnormalities
in any of the animals. At 0.5 mg/L, macroscopic examination revealed isolated black/brown
foci in the lungs of one male.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
2 000 mg/m³ air

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
Study period:
2019-2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
Version / remarks:
2017
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
other: Wistar Han
Sex:
female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test item was applied in an area of approximately 10% of the total body
surface, i.e. approximately 18 cm²
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 3 animals
Control animals:
not required
Key result
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the LD50 males of 200 mg/kg bw, 3-Pentenenitrile is classified for acute oral toxicity as:


- Category 3 (H301, Toxic if swallowed) according to the CLP Regulation (1272/2008) as LD50 was found to be between 50 and 300 mg/kg bw.


Based on the LD50 males of > 2000 mg/kg bw 3-Pentenenitrile is not classified for acute dermal toxicity,


 


Based on the LC50 males of > 0.5 - < 2.0 mg/L, 3-Pentenenitrile is classified for acute inhalation toxicity as:


- Category 2 (H330 Fatal if inhaled) according to the CLP Regulation (1272/2008) as LD50 was found to be between 0.5 and 2 mg/L/4h.