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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (short-term test)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
short exposure periods (3 m/ 1 h)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HEXAMETHYLENDIAMIN-RUECKSTAND, HMD-VORLAUF
- Analytical purity: 93.88%
- Impurities (identity and concentrations) > 0.1%: Aminoethylcyclopentylamine 3.57%, Hexamethylenimine 1.35%, Hexylmethylendiamine 0.74%, Pentylmethylendiamine 0.33%, other impurities 0.13%
- pH: 12-13 (10% aqueous solution)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 3.04 - 3.48 kg
- Housing: individually in cages of stainless steel with wire mesh walk floors, 40*51 cm
- Diet (e.g. ad libitum): Kliba 341, 4 mm, Klingenthalmuehle AG, Kaiseraugst, CH; ca. 130 g/d
- Water (e.g. ad libitum): tap water, ca 250 mL/d
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS in fully air-conditioned rooms
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL
Duration of treatment / exposure:
3 min, 1 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm on the upper third of the back or flanks

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)

SCORING SYSTEM: OECD Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: full thickness necrosis in all animals; see table for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1 h exposure
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: full thickness necrosis in all animals
Irritation parameter:
edema score
Basis:
mean
Remarks:
1 h exposure
Time point:
other: 24 - 48 -72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 72 h

Any other information on results incl. tables

Exposition:  3 min      
Animal  Reading * Erythema Edema Symptoms
1 3 m 4 2 necrosis
2 3 m 4 2 necrosis
3 3 m 4 2 necrosis
1 24 h 4 2 necrosis
2 24 h 4 2 necrosis
3 24 h 4 1 necrosis
1 48 h 4 1 necrosis
2 48 h 4 1 necrosis
3 48 h 4 0 necrosis
1 72 h 4 1 full thickness necrosis, confirmed by grosspathology
2 72 h 4 1 full thickness necrosis, confirmed by grosspathology
3 72 h 4 0 full thickness necrosis, confirmed by grosspathology
mean animal 1 24 - 72 h 4.00 1.33  
mean animal 2 24 - 72 h 4.00 1.33  
mean animal 3 24 - 72 h 4.00 0.33  
mean 24 - 72 h 4.00 1.00  

Exposition:  1 h      
Animal  Reading * Erythema Edema Symptoms
1 1 h  4 2 necrosis
2 1 h  4 2 necrosis
3 1 h 4 2 necrosis
1 24 h 4 2 necrosis
2 24 h 4 3 necrosis
3 24 h 4 2 necrosis
1 48 h 4 2 necrosis
2 48 h 4 2 necrosis
3 48 h 4 1 necrosis
1 72 h 4 1 full thickness necrosis, confirmed by grosspathology
2 72 h 4 1 full thickness necrosis, confirmed by grosspathology
3 72 h 4 1 full thickness necrosis, confirmed by grosspathology
mean animal 1 24 - 72 h 4.00 1.67  
mean animal 2 24 - 72 h 4.00 2.00  
mean animal 3 24 - 72 h 4.00 1.33  
mean 24 - 72 h 4.00 1.67  

* time after start of exposure

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the test substance induced skin corrosion in all animals.
Executive summary:

A skin irritation/corrosion test was performed according to OECD 404 with six rabbits. The animals were exposed to 0.5 ml of test substance on the clipped skin under semiocclusive conditions for 3 minutes or 1 h. The skin reactions were observed for 72 h after the initial exposure. All six animals showed severe skin corrosion.