propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10/2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

EC Number:

701-363-4

Molecular formula:

Not specified UVCB - Reaction product of ethoxylated (0-7 EO) propylidenetrimethanol with acrylic acid and dibutylamine (propylidenetrimethanol with acrylic acid : dibutylamine = 5:1)

IUPAC Name:

propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine

Details on test material:

- Name of test material (as cited in study report): Laromer LR8869
- Physical state: Liquid / colorless, clear
- Analytical purity: for details see analytical report no. 11L00263
- Purity test date: 2012-01-11
- Lot/batch No.: 110009P040
- Stability under test conditions: guaranteed by the sponsor
- Storage condition of test material: Room temperature; avoid temperatures > 25 °C; under light exclusion

Test animals

Species:

rat

Strain:

other: Wistar / Crl:WI (Han)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females: app. 12 weeks
- Weight at study initiation: males: 242-296g, females: 204-220g
- Fasting period before study: no
- Housing: single in Makrolon cage, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: >= 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: app. 40cm² (corresponds to at least 10% of body surface)
- fur clipped: 24h prior to application (dorsal and dorsolateral parts of the trunk)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze) and stretch bandage (Fixomull® Stretch)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.86ml/kg b.w.
- Concentration (if solution): undiluted

Duration of exposure:

24h

Doses:

2000mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: several times on the day of application, at least once daily thereafter on each workday
skin findings: 30-60 minutes after removal of the semi-occlusive dressing, several times until last day of observation
body weight: on day 0 prior to application, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, local skin reactions

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortatlity

Mortality:

no

Clinical signs:

other: male and female: no systemic effects male - local effects: In three males slight erythema (grade 1) was observed on study day 1 and 2. Well-defined erythema (grade 2) was observed in the two other animals on study day 1 and 2 after application. In these

Gross pathology:

no findings

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

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

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

· No signs of systemic toxicity were observed in the animals.

· The following test item-related local effects were recorded during the course of the study:

o Slight to well-defined erythema (grade 1 to 2)

o Very slight edema (grade 1)

o Incrustations

o Scaling

· The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not significantly change during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.

· No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.