m-phenylenebis(methylamine)

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

study conducted in the rat

Test guideline 2

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

Test material information

Constituent 1

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-(aminomethyl)phenyl]methanamine

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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.

Results 8

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.

Results 9

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

Results 10

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.