Registration Dossier

Administrative data

Description of key information

A single Local Lymph Node Assay (LLNA) has been performed using HCFO-1233yd(Z)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13/09/2018 - 07/11/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA): BrdU-ELISA
Species:
mouse
Strain:
CBA:J
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Test substance dissolved into vehicle at a concentration of 50%
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
None conducted.
Key result
Parameter:
SI
Value:
1.1
Variability:
0.07
Test group / Remarks:
25.0% concentration group
Key result
Parameter:
SI
Value:
1
Variability:
0.09
Test group / Remarks:
50.0% concentration group
Key result
Parameter:
SI
Value:
92.1
Variability:
0.08
Test group / Remarks:
92.1% concentration group
Interpretation of results:
GHS criteria not met
Conclusions:
Consequently, the SI's for the 92.1%, 50.0 and 25.0 w/v% were 1.10, 1.00 and 1.10: all the SIs were less than 1.6. Therefore, under the conditions tested, HCFO-1233yd(Z) was considered to be a non-sensitizer.
Executive summary:

Local lymph node assay: BrdU-ELISA was performed in accordance with the OECD TG 442B using female CBA/J mice, and the skin sensitization potential of HCFO-1233yd(Z) was assessed by calculating the stimulation index (SI).


In the pre-screen test, 92.1 %, 50.0 and 25.0 w/v% of test substance formulations, prepared with acetone: olive oil (4:1, v/v: AOO), were applied to the dorsum of both ears of one animal/dose level once daily for 3 consecutive days. Clinical observations, body weight measurements and ear thickness measurements were performed. As a result, no abnormal changes which suggested excessive irritation or systemic toxicity were detected. Thus, the dose levels of the main study were set at 92.1 %, 50.0 and 25.0 w/v%.


In the main study, in addition to the test substance groups, vehicle control group which was applied with AOO and positive control group which was applied with 25.0 w/v% ­hexylcinnamaldehyde (HCA) were set. The vehicle, HCA and test substance formulations were applied to the dorsum of both ears of 4 animals/group once daily for 3 consecutive days. Clinical observations and body weight measurements were performed. Approximately 48 hours after the final sensitization, 5-bromo-2-deoxyuridine (BrdU) was administered. Approximately 24 hours later, auricular lymph nodes were collected, the BrdU uptake levels were measured by ELISA, and the Sis were calculated. During the main study, no abnormal changes which suggested excessive irritation or systemic toxicity were noted. Therefore, all the data obtained were used to the skin sensitization evaluation.


Consequently, the SIs for the 92.1%, 50.0 and 25.0 w/v% were 1.10, 1.00 and 1.10: all the SIs were less than 1.6. Therefore, under the conditions tested, HCFO-1233yd(Z) was considered to be a non-sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:


BrdU-ELISA was performed in accordance with the OECD TG 442B using female CBA/J mice, and the skin sensitization potential of HCFO-1233yd(Z) was assessed by calculating the stimulation index (SI).


In the pre-screen test, 92.1 %, 50.0 and 25.0 w/v% of test substance formulations, prepared with acetone: olive oil (4:1, v/v: AOO), were applied to the dorsum of both ears of one animal/dose level once daily for 3 consecutive days. Clinical observations, body weight measurements and ear thickness measurements were performed. As a result, no abnormal changes which suggested excessive irritation or systemic toxicity were detected. Thus, the dose levels of the main study were set at 92.1 %, 50.0 and 25.0 w/v%.


In the main study, in addition to the test substance groups, vehicle control group which was applied with AOO and positive control group which was applied with 25.0 w/v% a­hexylcinnamaldehyde (HCA) were set. The vehicle, HCA and test substance formulations were applied to the dorsum of both ears of 4 animals/group once daily for 3 consecutive days. Clinical observations and body weight measurements were performed. Approximately 48 hours after the final sensitization, 5-bromo-2'deoxyuridine (BrdU) was administered. Approximately 24 hours later, auricular lymph nodes were collected, the BrdU uptake levels were measured by ELISA, and the Sis were calculated. During the main study, no abnormal changes which suggested excessive irritation or systemic toxicity were noted. Therefore, all the data obtained were used to the skin sensitization evaluation.


Consequently, the SIs for the 92.1%, 50.0 and 25.0 w/v% were 1.10, 1.00 and 1.10: all the SIs were less than 1.6. Therefore, under the conditions tested, HCFO-1233yd(Z) was considered to be a non-sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data indicates that classification for both skin sensitisation is not warranted.

HCFO-1233yd(Z) is not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).