Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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.