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:
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:
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 comprised very slight erythema (grade 1) in two out of five female animals on study day 1; in one of these animals the finding was observed until study day 3, in the other animal very slight erythema increased to well-defined erythema (grade 2) on study day 2 until day 3 and decreased afterwards to very slight erythema until study day 6.
In three out of five female animals well-defined erythema was noted on study day 1 until day 2 or 3 and decreased to very slight erythema on study day 3 or 6, respectively. One of these animals showed erythema grade 1 until day 7.
Very slight edema (grade 1) was noted in four animals from study day 1 until day 2 or 3, respectively. In two of these three animals scaling was noted on study day 7 only or from day 6 until day 7.
Body weight:
The mean body weight of the male animals increased throughout the study period within the normal range. As generally known for females dermally applied, the weight gain only slightly increased during the first week, but increased within the normal range in the second week.
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.