Ethylenediamine, propoxylated

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenediamine, propoxylated

EC Number:

500-035-6

EC Name:

Ethylenediamine, propoxylated

Cas Number:

25214-63-5

Molecular formula:

(C3H6O)n (C3H60)n (C3H6O)n(C3H6O)n C2H8N2 sum of n: >1 - 8.5

IUPAC Name:

Ethylenediamine, propoxylated

Details on test material:

Name: Ethylenediamine, propoxylated
Molecular weight: ca 280
Physical state: clear, colourless, viscous liquid
Lot number: 0037
Purity: not reported

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: Sprague-Dawley CD (BK:SD)
- Source: Bantin & Kingman, Hull, UK.
- Age: 8 - 12 weeks
- Weight at study initiation: at least 200g

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

ADMINISTRATION:
- Area covered: approx. 10% of the total body surface area
- Occlusion: semi-occlusive
- Vehicle: none, undiluted
- Doses: 2000 mg/kg bw
- Removal of test substance: after the 24-hour contact period, treated skin and surrounding hair wiped with distilled water

Duration of exposure:

EXAMINATIONS:
- Mortality and Clinical signs: ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days
Skin irritation: once daily

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Details on study design:

EXAMINATIONS:
- Mortality and Clinical signs: ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days
- Skin irritation: once daily
- Individual bodyweights: prior to dosing and seven and fourteen days after treatment
- Gross pathological examination: external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: No signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

SKIN IRRITATION: Well-defined erythema was noted at the treatment sites of all females one day after dosing. Very slight to well-defined erythema was noted at the treatment sites of four female animals two and three days after dosing with very slight erythema persisting at the treatment site of one female four days after dosing. Crust formation was noted at the treatment sites of two females two to five days after dosing and a hardened light brown-coloured scab was noted at the treatment site of one female three to fourteen days after dosing.

Applicant's summary and conclusion

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.