Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

To investigate the sensitising potential of the test substance a guideline compliant GLP study was performed according to the Bühler method.

A total of 40 guinea pigs were assigned to 3 groups:

- negative control: 5 males and 5 females

- positive control: 5 males and 5 females

- test control: 10 males and 10 females

24 h before the test, the left flank was cleared of hair (closely clipped) about 4 -6 cm2. On days 0, 7 and 14 the trst item was applied on a patch to the clipped skin of the left flank for 6 h for induction. On day 28 the test substance was applied on a patch to the clipped skin of the right flank for 6 h for challenge. 24 h anf 48 h after removal of the patches the skin reactions were scored.

In the positive control group 0.2 mL of 25% hexyl cinnamaldehyde was administered. There animals were treated identically to the test group. In the negative control group, the animals were challenged in the same way like the test group animals.

The results showed that under the conditions of this study, in the positive control group 2 of 5 females and 1 of 5 males developed erythema after the challenge treatment and the sensitisation rate was 30%. No skin reactions were observed in the negative and test substance group and the sensitisation rate was 0%. From the before mentioned results, it can be confirmed that the test system is stable and reliable.

The test substance is concluded to be no skin sensitiser.

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:
Apr - May 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: The Guidelines for the Testing of Chemical-health effects (2nd edition): 406 Skin Sensitization (China environmental press)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was required under Chinese chemical regulation
Specific details on test material used for the study:
Lot no.: 187-9-113-Y
Purity: >/=98.0%
light yellow liquid
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tianjin Yuda Experimental Animal Breeding Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation:
females: 208 - 230 g; males: 205 - 235 g
- Housing: stainless steel cage (LxWxH: 500 mm x 370 mm x 195 mm)
- Diet (e.g. ad libitum): formula feed for Guines pigs, Jaingsu Xietong Pharmaceutical Bio-enginering Co., Ltd., 35 g/day each animal
- Water (e.g. ad libitum): water from animal water dispenser (regularly analysed), ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 - 25.4 °C
- Humidity (%): 39.2 - 71.8 %
- Air changes (per hr): >/= 8
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES:
From: 25.04. To: 30.05.2019
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 mL of pure test substance
Day(s)/duration:
On days 0, 7 and 14 for 6 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 mL of pure test substance
Day(s)/duration:
On day 28 for 6 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Negative control:
5 females, 5 males
Psotive control:
5 females, 5 males
Test substance:
10 females, 10 males
Details on study design:
RANGE FINDING TESTS:
pre test for skin irritation reaction was performed.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (day 0, 7 and 14)
- Exposure period: 6 h each
- Test groups: 0.2 mL of pure test substance
- Control group:
positive control: hexyl cinnamic aldehyde; 0.2 mL of 25% positive control substance
negative control: no treatment during induction phase
- Site: approx. 4-6 cm(2) clipped area on the left flank
- Frequency of applications: once per application time
- Duration: 6 h
- Concentrations: 0.2 mL of pure test substance and 0.2 mL of 25% positive control substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (day 28)
- Day(s) of challenge: 1
- Exposure period: 6 h
- Test groups:
0.2 mL of pure substance
- Control group:
positive control: hexyl cinnamic aldehyde; 0.2 mL of 25% positive control substance
negative control: 0.2 mL of pure substance
- Site: clipped skin of the right flank
- Concentrations:
test item: 0.2 mL of pure substance
positive control: hexyl cinnamic aldehyde; 0.2 mL of 25% positive control substance
negative control: 0.2 mL of pure substance
- Evaluation (hr after challenge): 24 and 48 h after removal of patches
Positive control substance(s):
yes
Remarks:
25% hexyl cinnamaldehyde
Positive control results:
In the poisitve control group, 2 female animals and 1 male animal showed erythema after challenge exposure. The sensitisation rate was 30%. Thus, the positive control substance has to be classified as moderate sensitiser.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 mL pure test item
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no abnormal signs observed, no changes in body weight gain
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 mL pure test item
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
n.a.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
n.a.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.2 mL of 25% positive control item
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
no effects observed
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.2 mL of 25% positive test item
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
no effects observed
Remarks on result:
positive indication of skin sensitisation

Clinical observations:

No abnormal signs related to the test substance were observed in the animals during the test.

Body weights:

The animals in each group were weighed before and after the test. There was no obvious abnormal change in body weight.

Observation and scoring of the skin reaction:

No erythema and edema in skin were found in the negative control and test substance group. The scores of skin reaction were 0. In the positive group, 2 of 5 females and 1 of 5 males showed erythema in the skin (score 1).

Interpretation of results:
GHS criteria not met
Conclusions:
The sensitsation rate of the test item group was 0%. Therefore, the substance is considered to be non-sensitising.
Executive summary:

To investigate the sensitising potential of the test substance a guideline compliant GLP study was performed according to the Bühler method.

A total of 40 guinea pigs were assigned to 3 groups:

- negative control: 5 males and 5 females

- positive control: 5 males and 5 females

- test control: 10 males and 10 females

24 h before the test, the left flank was cleared of hair (closely clipped) about 4 -6 cm2. On days 0, 7 and 14 the trst item was applied on a patch to the clipped skin of the left flank for 6 h for induction. On day 28 the test substance was applied on a patch to the clipped skin of the right flank for 6 h for challenge. 24 h anf 48 h after removal of the patches the skin reactions were scored.

In the positive control group 0.2 mL of 25% hexyl cinnamaldehyde was administered. There animals were treated identically to the test group. In the negative control group, the animals were challenged in the same way like the test group animals.

The results showed that under the conditions of this study, in the positive control group 2 of 5 females and 1 of 5 males developed erythema after the challenge treatment and the sensitisation rate was 30%. No skin reactions were observed in the negative and test substance group and the sensitisation rate was 0%. From the before mentioned results, it can be confirmed that the test system is stable and reliable.

The test substance is concluded to be no skin sensitiser.

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the absence of any skin reactions in the available skin sensitisation study according to the Bühler method, the substance does not have to be classified as skin sensitiser according to Regulation (EC) No. 1272/2008 (CLP).