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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
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
Justification for type of information:
This in-vivo test was performed, because earlier in-vivo tests had experimental deficiencies and an in-vitro bovine cornea opacity test was inconclusive for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2017
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EC No 440/2008 Part B. Acute Toxicity, Eye Irritation/Corrosion
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
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, including recent versions up to 2019
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pent-3-enenitrile
EC Number:
225-060-7
EC Name:
Pent-3-enenitrile
Cas Number:
4635-87-4
Molecular formula:
C5H7N
IUPAC Name:
(3E)-pent-3-enenitrile
Details on test material:
- Name of test material (as cited in study report): 3-Pentenenitrile
- Analytical purity: > 95 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 h
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0 - <= 0.3
Max. score:
0.3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: very weak irritation, but fully reversible after 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0.3 - 1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: weak, but fully reversible irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Conclusions:
Based on these results, 3-PENTENENITRILE does not have to be classified and has no
obligatory labelling requirement for eye irritation according to the Globally Harmonized
System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017)
(including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling
and packaging of items and mixtures (including all amendments)