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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Remarks:
No deviations occurred that impacted the integrity of the study.
GLP compliance:
yes
Test type:
acute toxic class method
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: 3M Company, Batch 41-2601-2240-7 Lot #1
- Expiration date of the lot/batch: 30 November, 2005
- Purity test date:

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

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, test article dosed neat.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: Body weights were within 20% of the sex mean.
- Fasting period before study: Overnight before dosing.
- Housing: Group housing of three animals per sex per cage in labelled Macrolon cages.
- Diet (e.g. ad libitum): Pelleted laboratory animal diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libium
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6-20.8 C
- Humidity (%): 34-76
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 December, 2003 To: 13 January, 2004

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: None

MAXIMUM DOSE VOLUME APPLIED: 1.2 mL/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and viability were evaluated twice daily. Body weights were recorded on Day 1 (pre-administration), Day 8 and Day 15. Clinical signs were evaluated at periodic intervals on the day of dosing and once daily thereafter until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred during the stuy.
Clinical signs:
Signs of toxicity related to dose levels:
Hunched posture and/or piloerection were noted in all
females on days 1 and/or 2.
Body weight:
No test article-related body weight changes were noted.
Gross pathology:
No macroscopic abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
 Based on the results of the study, the oral LD50 for the test article is greater than 2,000 mg/kg body weight.
Executive summary:

The acute oral toxicity potential of the test article was evaluated in female Wistar rats. The study was conducted in compliance with OECD GLP (1997). The test method was based on OECD 423 (2001). A single dose of the test article was administered by oral gavage to two subsequent groups of three female wistar rats at 2,000 mg/kg body weight. Animals were observed for mortality (twice daily), clinical signs (periodically on dosing day, daily thereafter until Day 15), and body weights (Day 1, 8, and 15). Macroscopic examination was performed upon sacrifice (Day 15). No mortality occurred during the study. Hunched posture and piloerection were noted in all animals on Day 1 and hunched posture was noted in one animal on Day 2. Body weights were considered normal for all animals and no macroscopic abnormalities were noted upon necropsy. Based on the results of the study, the oral LD50 for the test article is greater than 2,000 mg/kg body weight.