Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
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.

Any other information on results incl. tables

Under the chosen test conditions, the test substance did not show significant toxicity upon single dermal exposure.

Applicant's summary and conclusion