1-Butanamine, N-butyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate

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:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (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:

2-(2-hydroxyethoxy)propyl prop-2-enoate; 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]butoxy]ethoxy]propyl 3-(dibutylamino)propanoate

EC Number:

605-658-8

Cas Number:

173011-06-8

Molecular formula:

Not specified UVCB - Reaction product of ethoxylated/propoxylated (0-6 EO; 0-6 PO) propylidenetrimethanol with acrylic acid and dibutylamine (acrylic acid : dibutylamine = 3:1)

IUPAC Name:

2-(2-hydroxyethoxy)propyl prop-2-enoate; 2-[2-[2-[2-(1-methyl-2-prop-2-enoyloxy-ethoxy)ethoxymethyl]butoxy]ethoxy]propyl 3-(dibutylamino)propanoate

Details on test material:

- Name of test material (as cited in study report):Laromer PO 83 F
- Analytical purity: 100 %
- Physical state: liquid / slightly yellow, clear
- Lot/batch No.: 120016P040

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 11-12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: About 40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used:

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male /5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. Skin effects at the application site comprised very slight erythema (grade 1) in all male animals and were observed from study day 1 until day 2. Skin effects at the application site co

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of Laromer PO 83 F after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.