Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 20, 1995 To December, 1995.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP OECD guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
EC Number:
217-288-0
EC Name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
Cas Number:
1800-91-5
Molecular formula:
C10H6F12
IUPAC Name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
Constituent 2
Reference substance name:
1,6 Divinylperfluorohexane
IUPAC Name:
1,6 Divinylperfluorohexane
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 7-9 weeks (on receipt)
- Weight at study initiation: Males: 225-250 g, Females: 200-225 g
- Fasting period before study: fasted overnight
- Housing: 5 animal/sex/cage in conditioned room; grill cages 40.5x38.5x18 cm
- Diet: GLP4RF21 (MucedolaS.r.l. Settimo M.se)
- Water : ad libitum
- Acclimation period: at least 5 days before the start of test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2
- Humidity (%): 55+/- 10
- Air changes (per hr): 20
- Photoperiod: 12 hrs dark / 12 hrs light (= 7 am - 7 pm)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.33 ml/kg (density 1.5 g/ml)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality were observed frequently on the first day after administration (at 30 min, 2h, 4h, 6h) and then twice a day/ Body weight was checked twice pre-trial (at randomization and on day 1 to calculate the administration volume) and on days 3, 8 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights.
Statistics:
By the method of the Probit, if possible.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died.
Clinical signs:
No general clinical signs or behavioral alterations were noted in any animal during the 14-day observation period.
Body weight:
The body weight gain during the observation period was within the normal limits for animals of this species and age.
Gross pathology:
The autoptic examination performed on animals killed at the end of the study did not show any change.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, the test article did not cause apparent sign of toxicity by oral route to rat at the single (limit) dose of 2000 mg/kg bw. Then, the acute oral LD50 of the test material in rats was determined to be greater than 2000 mg/kg bw. The test article is not classified according to CLP Regulation (EC 1272/2008).
Executive summary:

A study was performed with Sprague-Dawley rats to determine the acute oral toxicity of the test material. The study was performed according to the OECD guideline 401.The test substance was administered undiluted by gavage to groups of 5 male and 5 female fasted rats at the single (limit) dose of 2000 mg/kg bw. The animals were observed frequently after dosing. After that the animals were observed daily for clinical signs and twice daily for mortality. The bodyweight of the animals were determined at Day 0, 3, 8 and 14. Necropsy was performed on all animals. No animals died. No general clinical signs or behavioral alterations were noted in any animal during the 14-day observation period. The body weight gain during the observation period was within the normal limits for animals of this species and age. The autoptic examination performed on animals killed at the end of the study did not show any change. Under the test conditions, the acute oral LD50 of test material in rats was determined to be higher than 2000 mg/kg bw, thus the substance is not classified according to CLP Regulation (EC 1272/2008).