Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Oligomerisation products of o-Diaminotoluene with ethylene oxide and propylene oxide

EC Number:

614-144-2

Cas Number:

67800-94-6

Molecular formula:

C7 H10 N2. ( C3 H6 O )x.(C2 H4 O)y ; 1 < x + y < 8.5

IUPAC Name:

Oligomerisation products of o-Diaminotoluene with ethylene oxide and propylene oxide

Details on test material:

- Name of test material (as cited in study report): Lupranol VP 9234
- Molecular weight: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

8-12 weeks of age (males); 14-18 weeks of age (females); animals of comparable weight.
single housing with free access to drinking water and food throughout the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 and 200 mg/kg bw single dose

No. of animals per sex per dose:

three

Control animals:

no

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Mortality:

3/3 males died during hour 2 or on study day 1. No mortality occurred in the 200 mg/kg dose groups (0/3 males; 0/3 females)

Clinical signs:

other: 2000 mg/kg: impaired and poor general state, dyspnoea, apathy, staggering, cyanosis, salivation compulsory gnawing and piloerection (from hour 0 until hour 5 after administration) 200 mg: no signs of toxicity (males); salivation (one female, during hour 4

Gross pathology:

In one of the three male animals that died slight red discoloration in the small intestine was observed; no abnormalities were noted in 2 males that died and in the animals of the 200 mg/kg dose groups (3 males and 3 females)

Applicant's summary and conclusion

Conclusions:

The median lethal dose of the test substance after oral administration was found to be greater than 200 mg/kg and less than 2000 mg/kg b.w. for male and female rats.