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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation / corrosion: corrosive to the skin. Eye irritation: no data available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January - February 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
Method: Short-term test: 3 min, 1 h exposure (Draize-Test)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Housing: 1 animal per cage (stainless steel cage)
- Diet (e.g. ad libitum): Kliba 341 (130 g per animal per day)
- Water (e.g. ad libitum): 250ml per day per animal
- Acclimation period: at least 8 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 C°
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Duration of treatment / exposure:
3 min, 1 h
Observation period:
72 h
Number of animals:
3 min: 2 males, 1 female
1 h: 2 males, 1 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/Water (1:1)
Irritation parameter:
other: Full Thickness Necrosis after 3 min exposure
Basis:
other: 3 animals
Time point:
other: within 72 h
Remarks on result:
other: No full thickness necrosis
Irritation parameter:
other: Full Thickness Necrosis after 1 h exposure
Basis:
other: 3 animals
Time point:
other: within 72 h
Remarks on result:
other: Full thickness necrosis at day 3
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4

Readings

Animal

R

ED

Symptoms

3 min

1

2

1

HE

2

1

0

 

3

1

0

 

24 h

1

3

0

HE

2

0

0

 

3

0

0

 

48 h

1

3

0

HE

2

0

0

 

3

0

0

 

72 h

1

3

0

 

2

0

0

 

3

0

 

 

ME 24/48/72 h

1

3.0

0.0

 

ME 24/48/72 h

2

0.0

0.0

 

ME 24/48/72 h

3

0.0

0.0

 

ME

 

1.0

0.0

 

HE: Hemorrhage

 

Readings

Animal

R

ED

Symptoms

1 h

1

4

2

N

2

4

2

N

3

4

2

N

24 h

1

4

1

N

2

4

2

N

3

4

2

N

48 h

1

4

0

N

2

4

1

N

3

4

1

N

72 h

1

4

0

N/S2/+

2

4

1

N/S2/+

3

4

1

N/S2/+

ME 24/48/72 h

1

4.0

0.3

 

ME 24/48/72 h

2

4.0

1.3

 

ME 24/48/72 h

3

4.0

1.3

 

ME

 

4.0

1.0

 

N: Necosis; S2: Full Thickness Necrosis; +: Findings confirmed by Gross-Path. Examin.

 

Interpretation of results:
corrosive
Conclusions:
Classification: corrosive (causes burns)
Executive summary:

Skin corrosion was investigated in an pre-OECD Guideline and pre-GLP study (BASF AG, 1986). Three rabbits were semiocclusively exposed to N-(3 -Aminopropyl)-imidazole for 3 min and 1 h. Readings for edema and erythema scores were done within 1 h after exposure and at day 1, 2, and 3. After 3 min of exposure only 1 of 3 animals showed erythema and no edema were observed. After 1 h of exposure clinical signs of necrosis were observed in all 3 animals, which were confirmed by gross-pathological examination after incision of the skin. Therefore, N-3 -Aminopropyl)-imidazole is considered to be corrosive to the skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin corrosion was investigated in a pre-OECD Guideline and pre-GLP study (1986; RL2). Three rabbits were semiocclusively exposed to 1H-imidazole-1-propylamine for 3 min and 1 h. Readings for edema and erythema scores were done directly after exposure and at day 1, 2, and 3. After 3 min of exposure only 1 of 3 animals showed erythema and no edema were observed. After 1 h of exposure clinical signs of necrosis were observed in all 3 animals at day 3, which were confirmed by gross-pathological examination after incision of the skin. Therefore, 1H-imidazole-1 -propylamine is considered to be corrosive to the skin.


According to the REACh regulation, annex VII+VIII, 8.2 column 2, an eye irritation study does not need to be conducted due to the corrosivity of 1H-imidazole-1-propylamine.

Justification for classification or non-classification

GHS classification according to Annex I of the Regulation EC/1272/2008: Skin Corrosion Category 1B, H314, based on full thickness necrosis within 14 days observation period after 1 hour exposure.