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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 1a GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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): ortho-Toluene, ethoxylated and propoxylated
- purity: >= 99%

- Composition of test material, percentage of components: Propylene oxide (100%)
- Lot/batch No.: QC 28080735
- Storage condition of test material: room temperature in the dark, over silica gel

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS:
- Source: RCC Ltd Laboratory Animal Services, Switzerland
- Age: 8 to 10 weeks (males); 12-14 (females)
- Weight at study initiation: animals of comparable weight
- Group size: single housing

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

ADMINISTRATION:
- Area covered: approx 10% of total body surface
- application volume: 1.90 mL/kg

Duration of exposure:

24 hours

Doses:

single dose: 2000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

EXAMINATIONS:
During and after exposure, animals were observed for signs of toxicity several times on the day of application; at least once each workday for 14 days. At the end of the study, all animals were killed and subject to gross necropsy.

In addition to the standard observations blood methemoglobin levels were examined on the day prior to application and immediately after removal of the bandage.Methemoglobin was determined using a hemoximeter.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths during the study.

Clinical signs:

other: No signs of systemic toxicity and no local effects.

Gross pathology:

No abnormalities noted at necropsy

Other findings:

Minimal levels of methemoglobin were observed one day before application in one male
(0.3%) and one female (0.4%).
The blood samples taken immediately after removal of the bandage showed low levels of
methemoglobin (up to 1.5 %) in 9 animals. The mean value was 0.84%.
This indicates a slight increase of methemoglobin formation in the blood by the treatment with
2000 mg/kg body weight of the test substance.

Applicant's summary and conclusion

Conclusions:

The acute dermal median lethal does (LD50) was found to be greater than 2000 mg/kg bw in male and female rats. The test substance treatment induced a small increase in methemoglobin levels in the blood as compared to the pretreatment levels.