Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-05-08 to 2007-06-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented OECD Guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinyllaurate
- Substance type: industrial chemical
- Physical state: colourless liquid
- Impurities (identity and concentrations): not given
- Composition of test material, percentage of components: as stated in report
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 245-261 g (males) 183-194 g (females)
- Fasting period before study: not mentioned in the report
- Housing: controlled environment
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 - 23 °C
- Humidity (%): 38- 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2007-05-08 To: 2007-05-22

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% (25 cm2 for males, 18 cm2 for females)
- Type of wrap if used: surgical gauze patch/aluminim foil/Coban bandage/micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): not used
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw (2.296 ml/kg)
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: periodically on day one, once daily thereafter; weighting on days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
not applicable

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One male died on day 1.
Clinical signs:
Flat/hunched posture, piloerection Diarrhea, chromodacryorrhoea (snout) and/or ptosis were noted among the animals. The surviving animals recovered from the symptoms between day 2 and 4. Scales and scrabs were seen in the treated skin area of several animals during the observation period.
Body weight:
The body weight gain during the study was within the expected range for rats used in this type of study
Gross pathology:
No abnormalities were found
Other findings:
no other findings

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance has a LD50 > 2000 mg/kg bw.
Executive summary:

A group of five male and five female Wistar rats was treated with Vinyl laurate at 2000 mg/kg by single dermal application according to OECD Guideline 402 with a 14 days observation period. One animal died during the first day after application. Only slight signs of toxicity were not observed in the surviving animals like flat/hunched posture, piloerection Diarrhea, chromodacryorrhoea (snout) and/or ptosis. The animals recovered from the symptoms between day 2 and 4 of the study. Scales and scrabs were seen in the treated skin area of several animals during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy of the animals. The LD50 (dermal, rat) was determined to be > 2000 mg/kg bw.