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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study comparable to guideline (non GLP; occlusive conditions; 1 min, 5 min, 15 min or 20 hours treatment duration; applied volume of TS preparation: 1 mL, up to 8 days observation period)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Acceptable study comparable to guideline (non GLP; occlusive conditions; 1 min, 5 min, 15 min or 20 hours treatment duration; applied volume of TS preparation: 1 mL, up to 8 days observation period)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-4 Amin
- Analytical purity: > 97 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Weight at study initiation: 2.85 kg (mean)
- Diet: Ssniff

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL
Duration of treatment / exposure:
1, 5, 15 minutes, 20 hours
Observation period:
8 days
reading time points: 24 h and 8 days
Number of animals:
2 per treatment
Details on study design:
TEST SITE: area of test sites: 2.5 x 2.5 cm² on the animal back.

SCORING SYSTEM: Draize

2 animals were treated for 1, 5, 15 minutes and 2 other animals for 20 hours with undiluted test substance using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with test substance on a patch. In addition, skin from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals which had been treated for 20 hours were not washed after removal of the substance patch. The animals were observed 8 days and skin changes were recorded on working days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
animal #1
Remarks:
1 minute exposure
Time point:
other: 24 h
Reversibility:
fully reversible
Remarks on result:
other: smooth necrosis
Irritation parameter:
other: necrosis
Basis:
animal #2
Remarks:
1 minute exposure
Time point:
other: 72 h
Reversibility:
no data
Remarks on result:
other: laminar necrosis was observed on day 3
Irritation parameter:
other: necrosis
Basis:
animal #1
Remarks:
5 minute exposure
Time point:
other: 24, 48, 72 h
Reversibility:
not reversible
Remarks on result:
other: leathery necrosis
Irritation parameter:
other: necrosis
Basis:
animal #2
Remarks:
5 minute exposure
Time point:
other: 24, 48, 72 h
Reversibility:
not reversible
Remarks on result:
other: laminar necrosis
Irritation parameter:
other: necrosis
Basis:
animal #1
Remarks:
15 minute exposure
Time point:
other: 24, 48, 72 h
Reversibility:
not reversible
Remarks on result:
other: parchmentary necrosis
Irritation parameter:
other: necrosis
Basis:
animal #2
Remarks:
15 minute exposure
Time point:
other: 48, 72 h
Reversibility:
not reversible
Remarks on result:
other: parchmentary necrosis
Irritation parameter:
other: necrosis
Basis:
mean
Remarks:
20 hour exposure
Time point:
other: 24, 48, 72 h
Reversibility:
not reversible
Remarks on result:
other: parchmentary necrosis on day 1 after exposure which developed to leathery necrosis on day 2 and 3
Irritant / corrosive response data:
Laminar necrosis was found directly after 15 minute exposure in one animal which was still seen until animal died.

Any other information on results incl. tables

Undiluted N-4-Amin gave indication of slight edema and slight necrosis as a result of an exposure period of 1 minute. After application of the test substance for 5, 15 min and 20 hours, respectively, erythema and necrosis were observed.

Necropsy findings of the animals that died comprised enteritis and peritonitis with agglutinations. All findings were not reversible within 6 days.

Animal

Readings

Exposure period: 15 minutes

Erythema

Edema

Additional findings

01

24 h

2

2

 

48 h

2

2

parchment-like necrosis

72 h

2

2

parchment-like necrosis

Mean score

2

2

 

02

24 h

2

2

 

48 h

2

2

parchment-like necrosis

72 h

2

2

parchment-like necrosis

Mean score

2

2

 

 

 

Animal

Readings

Exposure period: 20 hours

Erythema

Edema

Additional findings

01

24 h

2

3

parchment-like necrosis

48 h

2

2

hard, relocatable necrosis

72 h

2

3

hard, relocatable necrosis

Mean score

2

2.7

 

02

24 h

2

2

parchment-like necrosis

48 h

2

2

leather-like necrosis

72 h

2

2

leather-like necrosis

Mean score

2

2

 

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information