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Description of key information

According to the criteria set under UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.4  DABCO NE 1550 it is not  classified as 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:
Study Initiation date: October 17, 2019 - Experimental Completation Date December 13, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Ministry of Environmental Protection of the People´s Repiblic of China: The Guidelines for Testing of Chemicals (HJ/T 153-2004) Appendix 406 Skin Sensitisation Test.

Ministry of Environmental Protection chemical registration center. The Guidelines for the Testing of Chemicals-Health Effects [M]. Appendix 406 Skin Sensitisation Test. The second edition. Beijing: China Environment press: 2013: 40-46.
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed within the aim of registration of the product for other regulatory program outside Europe.
Specific details on test material used for the study:
Test Item code: 2019C142
Product name: DABCO® NE 1550
Chemical name: 1,3-propanediamine, N1-(3-aminopropyl)-N1-[3-dimethylamino)propyl]-
N3,N3-dimethyl-, reaction products with propylene oxide
Molecular formula: C19H42N4O2
CAS number: 2044770-20-7 (new) 1900709-98-9 (old)
EC number: 816-324-8
Batch/Lot number: UR18201873
Purity: 100 %
Storage Conditions: Store at room temperature (10 – 30 °C)
Protective measures: According to the material safety data sheet provided by the client, uniform, masks, caps, gloves and glasses were used to ensure the health and safety of the personnel
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Liaoning Changsheng Biology Technology Co., Ltd
- Females (if applicable) nulliparous and non-pregnant: only male animals were used
- Microbiological status of animals, when known:
- Age at study initiation: 5 weeks (grouping)
- Weight at study initiation: 319.86- 380.14 g (grouping)
- Housing: The 2-6 guinea pigs were fed in a plastic cage (L 92 cm x W 62 cm x H 25 cm), and the housing condition followed the national standard (GB 14925-2010).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions: none

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.01-24.00 °C
- Humidity (%):40.00-69.40%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h light
- IN-LIFE DATES: From: October 17, 2019 To: December 13, 2019


Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted (100%)
Day(s)/duration:
21 days (three weeks treament). Inductiojn Exposure ( day 0, day 7 and day 14)
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25%
Day(s)/duration:
On day 28 for 6 hours. Observation were carried out at 1, 24 and 48 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Pre-Study: 2 animals were used randomly
Main Study: 20 animals in the treated group, 10 animals in the control group
Details on study design:
RANGE FINDING TESTS:
Pre-study
Animals: 2
Dosing Method: 0.2 mL undiluted (left flank first animal); 0.2 mL 50% of the test item solution(right flank of the first animal; 0.2 mL 25% of the test item solution (left flank of the second animal); 0.2 mL 12.5% of the test item solution (right flank on the second animal).
For every treatment the test patch systems were held in contact with skin by an occlusive patch and glutting by medical adhesive plaster.
The test patch systems were removed after 6 hours. Degreasing cotton was used for scrubbing the test area after removing the patch with ultrapure water.

Observation: The skin reaction was observed after removing the patch on 1st hour and 24th hour of treatment.
Dose design: The dose of the test item used for each induction exposure would cause highest irritation of mild irritation, and the dose used for the challenge exposure would be the highest non-irritation dose, according to the result of the pre-study. If all doses used in pre-study would not irritate skin, the highest dose would be used in induction and challenge.
Results: 0.2 mL test item was used in induction and 0.2 mL 25% was used in challenge

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Undiluted test sample was applied on the left flank cleared of air
- Control group: the same operation with the treated group was completed except test item
- Site: left flank
- Frequency of applications: 7 d interval (treatment on day 0, 7 and 14)
- Duration: 14 d
- Concentrations: undiluted

Degreasing cotton was used for scrubbing the test area after removing the patch with corn oil.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28, 14 d after final induction
- Exposure period: 6 h
- Test groups: 25% (w/v in water)
- Control group: 25% (w/v in water)
- Site: right flank
- Concentrations: 25% (w/v in water)
- Evaluation (h after challenge): 24 h and 48 h
Degreasing cotton was used for scrubbing the test area after removing the patch with corn oil.
Re-challenge was not carried out.
Positive control substance(s):
yes
Remarks:
The procedure for skin sensitisation study in guinea pigs used was validated, 2-mercaptobenzothiazole, as positive control test item. The test was started in May 24, 2019 and finished on June 27, 2019.
Positive control results:
The sensitisation incidence of 2-mercaptobenzothiazole was 30%. Thus, the experimental method and the animals used in this study were considered to be sentitive and reliable.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical observation
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical observation
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No abnormal findings in the treated guinea pigs in test
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
There was noabnormal general findings in the control and treated guinea pigs in test
Remarks on result:
other: one animal of the treated group was found discrete erythema on the test area, and the other 19 animals of the treated gropp were no visible changes
Interpretation of results:
GHS criteria not met
Conclusions:
The sensitisation incidence of the control group is 0% and the sensitisation incidence of the treated group is 5%. Thus, under the GHS classification criteria DABCO NE 1550 is not classified as skin sensitiser.
Executive summary:

The skin sensitization potential of DABCO NE 1550 was determined in guinea pigs following repeated dermal application in an OECD TG 406 study (Buehler Method) under GLP condition.


0.2 mL undiluted test item was used in induction, and 0.2 mL 25% test item was used in challenge.


0.2 mL was applied to the shaved left flank every treated animal (20 animals) once per week during the induction period of three consecutive weeks. The control guinea pigs (10 animals) were handled in the same manner, but without test item in the induction. About two weeks after the third exposure, 0.2 mL 25% test item solution was applied to the shaved right flank of the treated and the control guinea pigs in challenge.


Results: Following each induction, there were no visible changes of the control animals, all animals of the treated group were found slight erythema of test area.


After challenge, there was not visible changes of the control animals, while one animal of the treated group was found discrete erythema on test area, and other 19 animals of the treated group were no visible changes. The sensitization incidence is 5%.


Thus, under the GHS classification criteria DABCO NE 1550 is not classified as skin sensitiser.

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

The skin sensitization potential of DABCO NE 1550 was determined in guinea pigs following repeated dermal application in an OECD TG 406 study (Buehler Method) under GLP condition.


0.2 mL undiluted test item was used in induction, and 0.2 mL 25% test item was used in challenge.


0.2 mL was applied to the shaved left flank every treated animal (20 animals) once per week during the induction period of three consecutive weeks. The control guinea pigs (10 animals) were handled in the same manner, but without test item in the induction. About two weeks after the third exposure, 0.2 mL 25% test item solution was applied to the shaved right flank of the treated and the control guinea pigs in challenge.


Results: Following each induction, there were no visible changes of the control animals, all animals of the treated group were found slight erythema of test area.


After challenge, there was not visible changes of the control animals, while one animal of the treated group was found discrete erythema on test area, and other 19 animals of the treated group were no visible changes. The sensitization incidence is 5%.


Based on the study results no classification is required according to EU and GHS classification criteria for skin sensitisation.

Respiratory sensitisation

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

Justification for classification or non-classification

According to the criteria set under UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.4  DABCO NE 1550 it is not  classified as skin sensitiser. 

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