m-phenylenebis(methylamine)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

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:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

acute toxic class method

Limit test:

no

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): m-Xylenediamine (MXDA)

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Single doses of test material were administered to 5 groups of 10 rats

Doses:

Preliminary Study
709, 795, 892 and 1001 mg/kg

Main study
795, 1001, 1260, 1980 and 2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

The rats were observed for 14 days post dose. At termination, all surviving animals were killed and necropsied to allow reporting of gross findings.

Statistics:

LD50 values were calculated from the percentages via the method of Litchfield and Wilcoxon

Results and discussion

Preliminary study:

See below

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

930 mg/kg bw

95% CL:

>= 750 - <= 1 153

Remarks on result:

other: Calculated from the extended range of dosages used in main study

Mortality:

See table below

Clinical signs:

other: No data

Gross pathology:

See table below

Any other information on results incl. tables

Necropsy results for preliminary study

Dose mg/kg	Necropsy Data
709	No gross abnormalities were noted at 14 day necropsies
795	Slight irritation of the GI tract was noted in one rat which died on day 2. No gross abnormalities were noted in other rats.
892	Moderate irritation of GI tract was noted in 4 dead rats at 24 hours. No gross abnormalities were noted in other rats.
1001	Moderate GI tract irritation was noted in all rats

An LD50 value calculated from these data was reported as 880 mg/kg with 95% confidence limits of 779 -994 mg/kg

Mortality results for main study

Dose mg/kg	Day of Death		Total Dead/Total Tested
	1	2
795	2/10	1/10	3/10
1001	4/10	2/10	6/10
1260	6/10	2/10	8/10
1980	8/10	-	8/10
2000	10/10	-	10/10

Necropsy results for main study

Dose mg/kg	Necropsy Data
795	Very slight irritation of the GI tract in the 3 animals which died. No gross abnormalities were found in the animals necropsied at 14 days
1001	Very slight irritation of the GI tract in the 6 animlas which died. No gross abnormalities were found in the animals necropsied at 14 days
1260	Slight irritation of the GI tract was noted in the 8 animals which died. No gross abnormalities were noted in the animals necropsied at 14 days.
1580	Slight irritation of the GI tract was noted in the 8 animals which died. No gross abnormalities were noted in the other rats.
2000	Moderate irritation of the GI tract was noted in all animals.

Applicant's summary and conclusion

Conclusions:

The LD50 value was 930 mg/kg with 95% confidence limits of 750-1150 mg/kg