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Description of key information

The skin sensitization rate for Amidoaminethoxylate was 0 %: not sensitizing

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

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Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
other: modified method of Ritz, H.L. and Buehler, E.V. Current Concepts in Cutaneous Toxicity, ed. Drill, V.A. and Lazor, T. (Academics Press, 1980, pp. 25 - 40).
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test conducted according to guideline is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: S 44 099
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient

- Treatment of test material prior to testing: heated up to 80°C and cooled down to room temperature
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht, D-4791 Borchen
- Females (if applicable) nulliparous and non-pregnant: not specified
- Weight at study initiation: 287 - 361 g
- Housing: Macrolon plastc cages IV
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18° +- 2° C
- Humidity (%): -
- Photoperiod (hrs dark / hrs light):12/12
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.3 ml applied to the "Hill Top Chambers"
Day(s)/duration:
6 hour exposure once a week for 3 weeks
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
undiluted and 10 % dilution
Day(s)/duration:
animals remained untreated for 2 weeks before primary challenge
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
20 % and 5 % dilution
Adequacy of challenge:
not specified
No. of animals per dose:
10 male + 10 female in the test group
5 male + 5 female in the control group
Details on study design:
RANGE FINDING TESTS: yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 4
- Control group: 2
- Site: left shoulder
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: week 6
- Exposure period: 6 h
- Test groups: 4
- Control group: 2
- Site: left shoulder
- Concentrations: undiluted and 10 % dilution
- Evaluation (hr after challenge): 24 h and 48 h

OTHER:
Challenge controls:
5 male + 5 female animals; for rechallange new untreated control animals were used.
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
20 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Interpretation of results:
GHS criteria not met
Conclusions:
REWOPAL V 2762 causes no contact hypersensitivity in guinea pigs.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
other: GB/T 21608-2008 Chemicals - Test Method of Skin Sensitization
Version / remarks:
Chinese National Standard: The guidelines for the testing of chemicals (Ministry of Environment Protection of the People's Republic of China, 2004)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test conducted according to guideline is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TianQing biotechnology Ltd., ChangSha, China
- Females (if applicable) nulliparous and non-pregnant:not specified
- Housing: in common environment
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 55-66 %
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml
Day(s)/duration:
day 0 + 7 + 14
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 ml
Day(s)/duration:
14 days after last induction exposure
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.2 mL
Day(s)/duration:
7 days after first challenge
Adequacy of challenge:
not specified
No. of animals per dose:
test group: 20 animals
negative control group: 10 animals
positive control group: 20 animals
Details on study design:
RANGE FINDING TESTS: yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 1
- Control group: 2
- Site: left dorsal side
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 6 h
- Test groups: 1
- Control group: 2
- Site: right dorsal side
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 h + 48 h
Positive control substance(s):
yes
Remarks:
2,4-Dinitrochlorobenzene
Positive control results:
Sensitization rate: 90 %
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.06 %
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.06 %
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitization rate for REWOSOFT TE 19 L was 0 %: not sensitizing
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification