Registration Dossier

Administrative data

Description of key information

Amidoaminethoxylate was not irritating to skin of rabbits.

Amidoaminethoxylate is valuated as not irritant to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever Kaninchenfarm, D-2740 Bremervörde
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: single caging in battery of cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C +- 2°C
- Humidity (%): 50 - 85 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light):12/12

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
- Concentration (if solution): neat

Duration of treatment / exposure:
24 h
Observation period:
24 h, 48 h, 72 h
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: rubber sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
24 h, 48h, 72 h

On each rabbit two areas of the back were designated for the position of the patches. One of the areas was scarified by making epidermal incisions.
For evaluation the cumulative scores were averaged for both scarified and intact skin and were added together to calculate the primary irritation index.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
Rewopal V 2762 is not irritant to skin of rabbits.
Endpoint:
skin irritation: in vivo
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 21604-2008 Chemicals - Test method of acute dermal irritation/corrosion
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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: heated and melted
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TianQing biotechnology Ltd., ChangSha, China
- Age at study initiation: -
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: common environment
- Diet (e.g. ad libitum): -
- Water (e.g. ad libitum): -
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22°C
- Humidity (%): 55 - 66 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light):-
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): neat

Duration of treatment / exposure:
4 h exposure period
Observation period:
1, 24, 48 and 72 h after patch removal.
Number of animals:
2 male + 2 female animals
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed with water
- Time after start of exposure: at the end of the 4 h exposure period

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1 h, 24 h, 48 h, 72 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Very slight erythema was observed at the skin of one of the four animals at 24 h, and which faded away in 48 h. No any sign of erythema and edema was observed at the skin of the others during 24 h to 72 h.
Other effects:
no other effects reported
Interpretation of results:
GHS criteria not met
Conclusions:
REWOSOFT TE 19 iwas not irritating to skin of rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EEC-Guideline 84/449/EEC, 1984-09-19
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: S44 099
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in darkness


Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: single caging
- 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°C +- 2°C
- Humidity (%): 50 - 85 %
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Observation period (in vivo):
1h, 24h, 48h, 72h after treatment.
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): animals 4-6 with washing, animals 1-3 without washing
- Time after start of exposure: 4 se. p.a.


TOOL USED TO ASSESS SCORE: 1 % fluorescein dilution 24h and 72h p.a.

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.92
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.58
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Rewopal V 2762 is valuated as not irritant to eyes.
Endpoint:
eye irritation: in vivo
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 21609-2008 Chemicals -Test method of acute eye irritation/corrosion
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
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ST02697671
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: TianQing biotechnilogy Ltd, ChangSha, China
- Weight at study initiation: 2.0 - 2.4 kg bw
- Housing: common environment
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 - 22°C
- Humidity (%): 55 - 66 %

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): neat

Observation period (in vivo):
1h, 24h, 48h, 72h, 4d, and 7d
Number of animals or in vitro replicates:
2 female and 2 male
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
7 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
7 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
7 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
7 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Some blood vessels hyperaemic and crimson colour, some swelling above normal and obvious swelling, a little and moderate secreta were observed during 1 h to 4 days after application. There was one animal with the highest scores of redness and chemosis which was score 2. No irritation of cornea and iris was found. Body weight gain was in the normal range.
Interpretation of results:
GHS criteria not met
Conclusions:
Eye irritation intensity of REWOSOFT TE 19L was mild.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification