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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:
weight of evidence
Study period:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assesment

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
study conducted in the rat
Qualifier:
according to guideline
Guideline:
other: Evaluation of danger of unknown substances established by the Maritime Techniques Safety Bureau, Ministry of Transport (December 1985)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
study predates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
m-phenylenebis(methylamine)
EC Number:
216-032-5
EC Name:
m-phenylenebis(methylamine)
Cas Number:
1477-55-0
Molecular formula:
C8H12N2
IUPAC Name:
1,3-phenylenedimethanamine
Test material form:
liquid
Details on test material:
- Specific gravity: 1.050

Test animals

Species:
rat
Strain:
other: Crj-Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Crj-Wistar rats were supplied by Japan Charles River Co Ltd.
- Age at study initiation: 5 weeks; test material administered at 6 weeks
- Weight at study initiation: Initial weight not given but stated to be almost the same by sex

Test system

Type of coverage:
other: no covering used
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1mL/kg
- Concentration (if solution): Substance applied as supplied

Duration of treatment / exposure:
4 hours
Observation period:
4 hours
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: 1 square centimetre on the head

REMOVAL OF TEST SUBSTANCE
- Substance was not removed

SCORING SYSTEM: Corrosiveness of test substance evaluated based on dermal changes appearing at 3 minutes, 60 minutes and 4 hours after application in accordance with the criteria established by the International Maritime Organisation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
animal #1
Remarks:
male
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks:
not reversible within time period stated
Remarks on result:
other: test material was not removed
Irritation parameter:
other: necrosis
Basis:
animal #2
Remarks:
male
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks:
Not reversible within time period stated
Remarks on result:
other: test material was not removed
Irritation parameter:
other: necrosis
Basis:
animal #3
Remarks:
male
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks:
not reversible within time period stated
Remarks on result:
other: test material was not removed
Irritation parameter:
other: necrosis
Basis:
animal #4
Remarks:
female
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks:
not reversible within time period stated
Remarks on result:
other: test material was not removed
Irritation parameter:
other: necrosis
Basis:
animal #5
Remarks:
female
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks:
not reversible within time period stated
Remarks on result:
other: test material was not removed
Irritation parameter:
other: necrosis
Basis:
animal #6
Remarks:
female
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
no data
Remarks:
not reversible within time period stated
Remarks on result:
other: test material was not removed
Irritation parameter:
erythema score
Basis:
mean
Remarks:
both sexes
Time point:
other: 4 hours
Score:
2
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: erythema up to score 2 observed before 4 hours, but considered to be of low relevance due to severe necrosis early in the test.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
both sexes
Time point:
24/48/72 h
Reversibility:
other: see 'Remarks on results'
Remarks on result:
other: Experiment terminated 4 hours after application due to necrosis.
Irritation parameter:
edema score
Basis:
mean
Remarks:
both sexes
Time point:
other: 4 hours
Score:
4
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: significant oedema observed before and at 4 hours, but considered to be of low relevance due to severe necrosis
Irritation parameter:
edema score
Basis:
mean
Remarks:
both sexes
Time point:
24/48/72 h
Reversibility:
other: see 'Remarks on results'
Remarks on result:
other: Experiment terminated 4 hours after application due to necrosis.
Irritant / corrosive response data:
The individual scores for erythema, oedema, haemorrhage and necrosis are given in remarks on results including tables and figures.
Other effects:
Subcutaneous heamorrhage appeared after 3 minutes; brown metachromatic changes macroscopically judged to be necrosis emerged after 5 minutes. These changes showed highly necrotic appearance after 60 minutes; namely, the dark red-brown skin surfaces were slightly dried and hardened. Four hours after application, the cut surfaces showed necrosis throughout the entire dermal layers and severe heamorrhage reached the dorsal muscle.

Any other information on results incl. tables

The individual scores for erythema, oedema, haemorrhage and necrosis are shown in the following table:

 

Sex

No

Body Weight (g)

3 minutes

60 minutes

4 hours

Er

Ed

H

N

Er

Ed

H

N

Er

Ed

H

N

Rat

M

1

191

1

2

2

0

2

4

4

4

0

4

4

4

2

189

1

0

2

0

1

4

4

3

0

4

4

4

3

190

1

0

2

0

1

3

2

4

0

3

3

4

F

4

148

2

0

1

0

1

2

2

4

0

3

3

4

5

148

2

1

1

0

2

4

2

4

0

4

4

4

6

149

1

1

0

0

2

4

3

4

0

3

3

4

Symptoms: Er = Erythema, Ed = Oedema, H = Haemorrhage, N = Necrosis Severity: 0 = normal, 1 = very mild, 2 = mild, 3 = moderate, 4 = severe

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other:
Conclusions:
The substance was judged, based on the criteria of the International Maritime Organisation, to correspond to a corrosive substance classified as Packing grade II defined in the recommendations of the United Nations.

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