4-methyl-m-phenylenediamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

data not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The method is similar to accepted test guidelines. The purity of the substance is unknown. Compliance with GLP was not mentioned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-m-phenylenediamine

EC Number:

202-453-1

EC Name:

4-methyl-m-phenylenediamine

Cas Number:

95-80-7

Molecular formula:

C7H10N2

IUPAC Name:

4-methylbenzene-1,3-diamine

Constituent 2

Reference substance name:

1,3-diamino-4-methylbenzene

IUPAC Name:

1,3-diamino-4-methylbenzene

Details on test material:

- Name of test material (as cited in study report): pure m-Toluylendiamin (= tolamin-2,4)
no other data

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Stamm Wistar TNO W 74, Züchter: Winkelmann, Borchen
- Age at study initiation: 14 weeks
- Weight at study initiation: 155 g
- Fasting period before study: data not available
- Housing: 5 animals per cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: data not available


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Air changes (per hr): data not available
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: data not available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: lutrol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): data not available
- Justification for choice of vehicle: data not available
- Lot/batch no. (if required): data not available
- Purity: data not available


MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses:

500, 100, 70, 50 and 10 mg/kg

No. of animals per sex per dose:

10 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: two-fold per day (one-fold per Week-end)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no data

Results and discussion

Preliminary study:

No preliminary study was performed.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

73 mg/kg bw

95% CL:

60 - 90

Mortality:

Mortality was observed at 50 mg/kg (1/10), 70 mg/kg (5/10), 100 mg/kg (8/10) and 500 mg/kg (10/10)

Clinical signs:

other: Bad general appearance, sedation and loss of body weight.

Gross pathology:

At necropsy, no macroscopically visible changes were detected.

Other findings:

no data

Any other information on results incl. tables

Table 1: Number of animals dead and day or time range within mortality occured

Dose (mg/kg bw)	Mortality (# dead/total)			Day or time range of deaths (days)
	female
500	10/10			(1 -2)
100	8/10			(3 -10)
70	5/10			(1 -4)
50	1/10			(3)
10	0/10			-

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is considered as toxic according to EU criteria and is classified in Category 3 according to the EU-GHS

Executive summary:

In an acute oral toxicity study (Bayer 1981, unpublished report), groups of 14 weeks old wistar female rats (10 females per group) were given a single oral dose of pure 2,4 -toluylene diamine in lustrol at doses of 500, 100, 70, 50 and 10 mg/kg bw and observed for 14 days. A dose of 10 mg/kg did not cause mortalities or clinical signs in this test. 1/10 female rats died after application of 50 mg/kg at day 3; 5/10 died after application of 70 mg/kg within 4 days; 8/10 did after 100 mg/kg and 10/10 after application of 500 mg/kg. Clinical signs observed included bad general appearance, diuresis and loss of body weight. At necropsy, no macroscopically visible changes were detected. In this test similar to current OECD guidelines, an oral LD50 value of 73 mg/kg bw was determined for female rats. Therefore, 2,4 -toluylene diamine is considered as toxic according to EU criteria and is classified in Category 3 according to the EU-GHS.