Diaminotoluene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

environmental conditions were not reported and observation period was only 7 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-m-phenylenediamine

EC Number:

212-513-9

EC Name:

2-methyl-m-phenylenediamine

Cas Number:

823-40-5

Molecular formula:

C7H10N2

IUPAC Name:

2-methylbenzene-1,3-diamine

Constituent 2

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 3

Reference substance name:

4-methyl-3-phenylenediamine

IUPAC Name:

4-methyl-3-phenylenediamine

Details on test material:

- Name of test material (as cited in study report): TDA 8020
no other data

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: data not available
- Age at study initiation: data not available
- Weight at study initiation: 160-180 g
- Fasting period before study: data not available
- Housing: data not available
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: data not available


ENVIRONMENTAL CONDITIONS
- Temperature (°C): data not available
- Humidity (%): data not available
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available


IN-LIFE DATES: data not available

Administration / exposure

Type of coverage:

occlusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: data not available
- % coverage: data not available
- Type of wrap if used: data not available


REMOVAL OF TEST SUBSTANCE
No


TEST MATERIAL
- For solids, paste formed: yes


VEHICLE
data not available

Duration of exposure:

24 hours

Doses:

50, 100, 250, 500, 750 and 1000 mg/kg

No. of animals per sex per dose:

5 to 10 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: data not available
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

LD50 was calculated accordint to Litchfield and Wilcoxon method.

Results and discussion

Preliminary study:

No preliminary study.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

463 mg/kg bw

95% CL:

326 - 658

Mortality:

Mortality was observed at 250 mg/kg bw (2/10), 500 mg/kg bw (5/10), 750 mg/kg bw (8/10) and 1000 mg/kg bw (5/5) (see Table 1).

Clinical signs:

other: Clinical signs observed included bad general appearance, disturbance of respiration and convulsions starting at about 1 hour after application and lasting till the end of the study at day 7. At higher doses, paralysis of hind legs and cyanosis were observ

Gross pathology:

At higher doses blue-black discolouration of skin and subdermis, sub-serous and petechial haemorrhages in stomach, ulcera in the gastro-intestinal tract, discoloured kidneys, changes in the liver and enlarged adrenals were detected at necropsy.

Other findings:

No

Any other information on results incl. tables

Table 1: Number of females dead and with evident toxicity and time range within which mortality occured

Dose (mg/kg bw)	Mortality (# dead/ total)	Time range of deaths (days)	Number with evident toxicity (#/ total)
50	0/5	-	0/5
100	0/5	-	5/5
250	2/10	4 -6	10/10
500	5/10	2 -6	10/10
750	8/10	2 -3	10/10
1000	5/5	2 -3	5/5

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test, TDA 80/20 is considered as harmful according to EU criteria and is classified in category 3 according to EU-GHS.

Executive summary:

In an acute dermal LD50 study (Bayer unpublished report, 1974), five or ten Wistar female rat were exposed to TDA 80/20 moistened with arachis oil at the dose levels of 50, 100, 250, 500, 750 and 1000 mg/kg bw. The animals were then observed for 7 days. Mortality was observed at 250 mg/kg bw (2/10), 500 mg/kg bw (5/10), 750 mg/kg bw (8/10) and 1000 mg/kg bw (5/5). Clinical signs observed included bad general appearance, disturbance of respiration and convulsions starting at about 1 hour after application and lasting till the end of the study at day 7. At higher doses, paralysis of hind legs and cyanosis were observed. The animals dosed at 50 mg/kg did not demonstrate any macroscopically visible changes at necropsy. At higher doses blue-black discolouration of skin and subdermis, sub-serous and petechial haemorrhages in stomach, ulcera in the gastro-intestinal tract, discoloured kidneys, changes in the liver and enlarged adrenals were detected at necropsy. Under the conditions of this test, TDA 80/20 is considered as harmful according to EU criteria and is classified in category 3 according to EU-GHS.