m-phenylenebis(methylamine)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

TK 11813 was applied to a shaved area of approximately 60 square cm on the backs of rats and the animals were observed until necropsy on day 14

GLP compliance:

no

Remarks:

study predates GLP

Test type:

fixed dose procedure

Limit test:

yes

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:

- Name of test material (as cited in study report): TK 11813

Test animals

Species:

rat

Strain:

other: Tif RAIf (SPF) random bred

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy, Basle, Switzerland
- Weight at study initiation: 180-200 g
- Housing: Individually in Macrolon cages (type 2)
- Diet: NAFAG, Gossau SG rat food ad libitum
- Water: Ad libitum
- Acclimation period: Minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 degrees Centigrade
- Humidity: 55 ± 5 %
- Photoperiod: 14 hours light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours before treatment, an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper. The substance was then evenly dispersed on the skin with a syringe and was covered with an occlusive dressing, which was fastened round the trunk with an adhesive elastic bandage. After 24 hours, the dressing was removed, the skin cleaned with lukewarm water and the reaction of the skin was appraised.

Duration of exposure:

24 hours

Doses:

2150 mg/kg and 3170 mg/kg

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

No data

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 100 mg/kg bw

Based on:

test mat.

Remarks on result:

other: TK 11813 is described only as a concentrate in the study report and no information is available on the percentage of m-phenylenebis(methylamine)

Mortality:

See Table 1 (below)

Clinical signs:

other: Within 24 hours after treatment, the rats in both dosage groups showed dyspnoea, curved position and ruffled fur. Five to seven days after treatment, a severe erythema developed into necrosis. The animals recovered from systemic symptoms within 9 to 13 da

Gross pathology:

No substance related gross organ changes were seen

Other findings:

No data

Any other information on results incl. tables

Table 1 - Rate of deaths

Dose (mg/kg)	Concentration % of formulation	Number of animals		Died within
				1 h		24 h		48 h		7 d		14 d
		♂	♀	♂	♀	♂	♀	♂	♀	♂	♀	♂	♀
2150	conc	3	3	0	0	0	0	0	0	0	0	0	0
3170	conc	3	3	0	0	0	0	0	0	0	0	0	0
No higher doses were possible

Applicant's summary and conclusion

Conclusions:

The acute LD50 of TK 11813 in rats of both sexes observed over a period of 14 days is greater than 3100 mg/kg. The substance therefore has a slight acute toxicity to the rat by this route of administration.