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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Remarks:
No deviations occurred that impacted the integrity of the study.
Principles of method if other than guideline:
Organisation for Economic Co-operation and Development
(OECD), OECD Guidelines for Testing of Chemicals, Section 4,
Health Effects, No.404: "Acute Dermal Irritation /
Corrosion", Paris Cedex, 2002.


European Community (EC), Council Directive 67/548/EEC, Annex
V, Part B, Methods for the Determination of Toxicity, as
last amended by Commission Directive 2004/73/EC, B.4: "Acute
Toxicity: Dermal Irritation/ Corrosion", 2004.


United States Environmental Protection Agency (EPA). Health
Effects Test Guidelines, OPPTS 870.2500, Acute Dermal
Irritation. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-98-196, August 1998.


Japanese Ministry of Agriculture, Forestry and Fisheries
(JMAFF), 12 Nousan, Notification No 8147, November 2000,
including the most recent partial revisions.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Novec 7300
IUPAC Name:
Novec 7300
Details on test material:
- Name of test material (as cited in study report): Novec 7300
- Physical state: Colorless, clear liquid
- Analytical purity: 99.85%
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 41-2601-2240-7
- Expiration date of the lot/batch: 23 March, 2006
- Purity test date: 10 June, 2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING : The test article was applied neat.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 12 weeks
- Weight at study initiation: Females: 210-256 g, Males: 354-386 g
- Fasting period before study: None
- Housing: Individually housed in Macrolon MIII type cages.
- Diet (e.g. ad libitum): Altromin pelleted lab animal diet ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22.7
- Humidity (%): 27-72
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18 May, 2005 To: 01 June, 2005

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The animal's back (18 cm^2 for females, 25 cm^2 for males)
- % coverage: 10
- Type of wrap if used: The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandage in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with tap water
- Time after start of exposure:24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2,000 mg/kg body weight.
Duration of exposure:
24 h
Doses:
2,000 mg/kg
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 for mortality were conducted twice daily. Body weights were measure on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross 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.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Scabs or scales were noted in the treatment are of two females between day 7 and 15. No other clinical signs were noted.
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 gross abnormalities were observed at necropsy.
Other findings:
Signs of toxicity (local):
Chromodacryorrhoea was noted among the animals on day 1.

Scabs or scales were noted in the treated skin-area of two
females between day 7 and 15.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, the acute dermal LD50 of the test article is greater than 2,000 mg/kg body weight in male and female rats.
Executive summary:

The acute dermal lethality potential of MTDID 665 was evaluated in male and female Wistar rats. The study was conducted according to OECD No. 402 (1987). The study was conducted in compliance with OECD GLP. MTDID 665 (liquid - dosed undiluted) was administered to 5 Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight and held in place for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrafice (day 15). No mortality occurred. Chromodacryorrhoea was noted among animals on day 1. Scabs or scales were noted in the treated skin area of 2 females between day 7 and 15. The body weight gain during the observation period was within the range expected. No abnormalities were found at the macroscopic post mortem examination. The dermal LD50 value of MTDID 665 was established to exceed 2000 mg/kg. Based on these results, the material does not have to be classified and has no obligatory labeling requirement for dermal toxicity according to GHS.