Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-[[3-[[3-(dimethylamino)propyl]amino]-1-oxo-2-butenyl]oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)

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:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate

EC Number:

613-645-3

Cas Number:

646505-36-4

Molecular formula:

see structural formula

IUPAC Name:

Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: HsdCpb: Wu
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: approximately 9-13 weeks
- Diet and water: ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
One day before the start of the treatment the back and flanks of the rats were shorn (approximately 10 % of the body surface area). For each dose and animal the required amount of the pure liquid test substance was calculated on the base of the body weight at time of dosing. This amount was weighed and applied as uniformly and thinly as possible to the test area, covered with a gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a "Cutiplast steril" coated with "Leukoflex". The gauze strip was placed on the rat's back and secured with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
After approximately 24 hours the dressings were removed and the area was rinsed with tepid water using soap and gently patting the area dry.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw per 30.0 cm²
Dose range: males 18.9 - 19.5 mg/cm²; females 14.6 - 15.7 mg/cm².

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: at least 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of application and subsequently at least once daily. The weight gain of the animals was checked weekly until the end of the study.
- Necropsy of survivors performed: yes

Statistics:

none; limit dose study; judgement according to the Globally Harmonization System (GHS) in analogy with the OECD Draft Guideline 434.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no clinical signs, no effects on weight development and no gross pathological findings; local effects: partial reddening of the treatment area in one male and one female

Mortality:

No mortalities occured.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

The necropsies performed at the end of the study revealed no particular findings.

Other findings:

partial reddening of the treatment area in one male (day 2) and one female (day 2-3) animal

Applicant's summary and conclusion

Executive summary:

An acute dermal toxicity study (limit test) was performed on male and female rats according to OECD TG 402. No mortalities, clinical signs, effects on body weight or gross pathological findings were observed during the 14 -day observation period. Local effects became obvious as partial reddening of the skin in one male and one female rat. The resulting dermal LD50 was > 2000 mg/kg bw.