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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
yes
Remarks:
Test item formulations not tested for stability, concentration and homogeneity. However, formulations preparations described in detail and visually inspected for homogeneity before use. All preparations used within 4 h after preparation.
Qualifier:
according to guideline
Guideline:
other: EC No 440/2008 Part B. Skin Sensitization: Buehler
Version / remarks:
May 2008
Deviations:
yes
Remarks:
Test item formulations not tested for stability, concentration and homogeneity. However, formulations preparations described in detail and visually inspected for homogeneity before use. All preparations used within 4 h after preparation.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
March 2003
Deviations:
yes
Remarks:
Test item formulations not tested for stability, concentration and homogeneity. However, formulations preparations described in detail and visually inspected for homogeneity before use. All preparations used within 4 h after preparation.
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 revisions up to 2019
Deviations:
yes
Remarks:
Test item formulations not tested for stability, concentration and homogeneity. However, formulations preparations described in detail and visually inspected for homogeneity before use. All preparations used within 4 h after preparation.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The guinea pig Buehler test was selected as the test item belongs to the nitrile class of
substances which are poorly predicted by the LLNA test. Initially the study was started as a Guinea pig Max.-test. This resulted in mortality and deterioration of animals directly after injection of the test solutions. The Buhler test could however be conducted.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
50%
Day(s)/duration:
6 h on day 1, 8 and 15
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
50%
Day(s)/duration:
6h on day 28
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 animals with 50% dose
Challenge controls:
10 animals
Positive control substance(s):
no
Remarks:
ALPHA-HEXYLCINNAMALDEHYDE was used as periodic positive control
Positive control results:
10/10 animals were positive after challenge (periodic control test)
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %, only vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no irritation after challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%, only vehicle
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no irritation after challenge
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reactions were evident after the challenge exposure in the experimental and control
animals.
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of
the main study.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Slight erythema and oedema were noted for the experimental animals during the induction
phase. No skin effects were noted for the controls.
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of
the main study.
Interpretation of results:
GHS criteria not met
Conclusions:
There was no evidence that 3-PENTENENITRILE had caused skin hypersensitivity in the
guinea pig, since no responses were observed in the experimental animals in response to a
50% test item concentration in the challenge phase.
This result indicates a sensitization rate of 0 per cent.
Based on these results 3-PENTENENITRILE does not have to be classified and has no
obligatory labelling requirement for sensitization by skin contact 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).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

3-Pentenenitrile is not classified as skin sensitizer according to the EU legislation (Directive 67/548/EEC and Regulation 1272/2008/EC).