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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Perfluorpropylvinylether (PPVE), MTDID 16437
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 98.5%
- Storage condition of test material: At room temperature in the dark under nitrogen
- Other: Flush container with nitrogen after handling
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch: 114B1005
- Expiration date of the lot/batch: No data
- Purity test date: 08 April, 2014

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, in the dark, under nitrogen
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No vehicle was utilized

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Male mean: 293 grams, Female mean: 196 grams
- Fasting period before study: None
- Housing: Individually in Makrolon cages (MIII type, height 18 cm) containing sterilized sawdust as b edding material and paper as cage enrichment.
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiaten GmbH, Soest, Ge rmany) ad libitum - Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days before the start of treatment.

ENVIRONMENTAL CONDITIONS - Temperature (°C): 18-24 - Humidity (%): 40-70 - Air changes (per hr): 10 - Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 June 2014 To: 03 July 2014

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The exposure area was on the back of the animal
- % coverage: 10
- Type of wrap if used: The test substance was held in contact with the skin with a dressing consisti ng of a gauze patch covered in aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed after 24 hours with tap water. - Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (1.29 mL/kg) body weight.
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
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: Clinical signs were recorded periodically on the day of dosing and once daily thereafter. Body weights were recorded on study Day 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examinations at necropsy.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality occurred during the study period.
Clinical signs:
Restless behavior (4/5 males, 5/5 females) was noted from 0-4 hours following test article administr ation. Piloerection and chromodacryorrhea were noted in animals on Day 1 only.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, the dermal LD50 of the test article is greater than 2000 mg/kg body weight.
Executive summary:

The acute dermal toxicity of the test article (clear, colorless liquid, batch 114B1005) was evaluated in male and female Sprague-Dawley rats. This study was performed in compliance with OECD GLP regulations. The test method was based on OECD 402 (1987). Rats (5/sex) were clipped of hair to create a dorsal trunk test site that was not less than 10% of the total body surface area. Animals were dosed with 2000 mg/kg (1.29 mL/kg) of the test article. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only. At 24 hours, the wrappings were removed and the test sites were washed with tap water. Clinical observations were recorded periodically on the day of dosing and then once daily for 14 days. Body weights were recorded pretest, day 8 and day 15. All animals were examined for gross pathology after termination on Day 15. All animals survived. Restless behavior, piloerection and/or chromodacryorrea were noted for the animals on day 1. The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity. No abnormalities were found at macroscopic post mortem examination of the animals. Based on the results of this study, the dermal LD50 of the test article is greater than 2000 mg/kg.